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EU Clinical Trial 2007-004675-19 – EMA – Jan 17, 2008

THE EFFECTS OF SIMVASTATIN IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Main objective of the trial: To determine the effects of 2 months therapy with simvastatin 40mg once per day compared to placebo in a double-blind placebo-controlled study of patients with COPD
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EU Clinical Trial 2007-000451-34 – EMA – Oct 1, 2007

Therapy of hyperhomocysteinemia in hemodialysis patients:effects of acetylcysteine and folates.

Main objective of the trial: We propose to evaluate the efficacy, in terms of its homocysteine-lowering effect, of ev acetylcysteine in a group of folate-replete hemodialysis patients. Acetylcysteine will be administered during the course of the dial...
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EU Clinical Trial 2005-002089-13 – EMA – May 26, 2006

International Phase II Studies of 131I-mIBG in combination with topotecan and peripheral blood stem cell rescue for (A) primary resistant high risk neuroblastoma and (B) relapsed stage 4 neuroblastoma

Main objective of the trial: To investigate a novel combination of mIBG given at a higher dose than usual in conjunction with topotecan. There is good experimental evidence to indicate that this may yield better results. Primary resistant high risk n...
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EU Clinical Trial 2006-002000-34 – EMA – Apr 9, 2007

CLOZAPINA EN PRIMEROS BROTES DE ESQUIZOFRENIA COMO POSIBLE TRATAMIENTO PREVENTIVO DEL DETERIORO CEREBRAL Y CLINICO

Main objective of the trial: Basical and clinical data suggest its potential for the treatment in early stages of the illness, when the deterioration rate can be faster. In this project our aim is to confirm that clozapine may limit the rate of gray...
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EU Clinical Trial 2005-000175-17 – EMA – May 31, 2005

A pharmacokinetic study to assess Nevirapine levels in HIV-infected patients with impaired hepatic function.

Main objective of the trial: To evaluate the steady state clearance of nevirapine among hepatically impaired patients, and to examine whether the degree of hepatic impairment influences clearance
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EU Clinical Trial 2004-004707-38 – EMA – Apr 8, 2005

A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magnetic resonance imaging (MRI) defined poor risk rectal cancer.

Main objective of the trial: To evaluate the improvement in pathological complete response rate from the addition of cetuximab to neoadjuvant oxaliplatin and capecitabine followed by synchronous chemoradiation and total mesorectal excision in patient...
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EU Clinical Trial 2011-001148-31 – EMA – Sep 13, 2011

A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease

Main objective of the trial: To assess whether 6 month treatment with Deferiprone is well tolerated by PD patients and assess whether such treatment removes excess iron in the brain area affected in PD, the substantia nigra, as assessed by MRI.
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EU Clinical Trial 2005-001195-13 – EMA – Aug 18, 2005

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project: An open label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for prison primary care detoxification from either heroin or methadone

Main objective of the trial: To evaluate whether buprenorphine (subutex) or methadone, given openly to heroin users presenting for detoxification in the UK NHS Prison setting, helps achieve abstinence at completion of the regime
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EU Clinical Trial 2011-003803-39 – EMA – Aug 8, 2012

Pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin

Main objective of the trial: The proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this stu...
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EU Clinical Trial 2014-003710-84 – EMA – Nov 27, 2014

The Central Nervous System Effects of Two Different HIV-Integrase Inhibitor Containing Antiretroviral Regimens.

Main objective of the trial: The aim of the study is to compare cerebral function parameters in HIV-infected subjects receiving two different integrase-inhibitor containing antiretroviral regimens by assessing the following questions: -Principal rese...
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EU Clinical Trial 2009-013897-42 – EMA – Apr 27, 2010

STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis

Main objective of the trial: To determine whether prednisolone or pentoxifylline improve the 28 day mortality (death rate) from severe alcoholic hepatitis.
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EU Clinical Trial 2013-003219-22 – EMA – Jan 27, 2014

A randomised controlled feasibility trial comparing clinical and cost effectiveness of cognitive behavioural therapy (CBT) and selective serotonin reuptake inhibitors (SSRI) and their combination in the management of obsessive compulsive disorder.

Main objective of the trial: The main research question is to find out whether it is possible to carry out a randomised study looking at whether sertraline alone or cognitive behavioural therapy alone or a combination of both sertraline and cognitive...
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EU Clinical Trial 2015-001439-20 – EMA – Jul 30, 2015

A Feasibility Randomised Controlled Trial: Effects of Oral Sodium Bicarbonate Supplementation in Patients on Haemodialysis

Main objective of the trial: Principal research question: What are the effects of oral sodium bicarbonate supplementation in haemodialysis patients? Principal objective: Investigate the effect of oral sodium bicarbonate supplementation on blood potas...
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EU Clinical Trial 2007-001374-87 – EMA – Jul 17, 2007

An open-label, multicenter study to evaluate the efficacy and tolerability of a 4 week therapy with the fixed dose combination of amlodipine 10 mg plus valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy with the free combination of an angiotensin receptor blocker (olmesartan 20 mg) plus amlodipine 10 mg

Main objective of the trial: To demonstrate that 4 weeks of treatment with amlodipine 10 mg plus valsartan 160 mg in fixed dose combination provide an additional mean sitting diastolic blood pressure reduction in patients not adequately responding (i...
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EU Clinical Trial 2007-004726-24 – EMA – May 7, 2008

A multicenter, double-blind, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of once daily amlodipine/valsartan 5/80mg as compared to amlodipine/valsartan 5/40mg or to amlodipine 5mg once daily in elderly patients with essential hypertension not adequately controlled after four weeks on amlodipine 5mg once daily

Main objective of the trial: The primary objective of this trial is to evaluate the overall safety and tolerability profile of a regimen of amlodipine/valsartan 5/80 mg as compared to a regimen of amlodipine/valsartan 5/40 mg (with optional titration...
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EU Clinical Trial 2009-012057-38 – EMA – Aug 13, 2009

A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study

Main objective of the trial: • To evaluate the efficacy of QTI571 compared to placebo as measured by the change in 6-minute walk distance (6MWD) from baseline to 24-weeks
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EU Clinical Trial 2007-002171-13 – EMA – Nov 22, 2007

A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY T-CELL NON-HODGKIN’S LYMPHOMA

Main objective of the trial: •To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell NHL. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and prog...
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EU Clinical Trial 2008-000663-42 – EMA – Jun 3, 2008

A 26-week extension to a 26-week treatment, multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless, parallel-group study to assess safety, tolerability and efficacy of two doses of indacaterol (150 and 300 μg o.d.) in patients with chronic obstructive pulmonary disease.

Main objective of the trial: To assess the safety of two indacaterol doses (150 and 300 μg o.d. via SDDPI) in patients with moderate to severe COPD as compared to placebo after 52 weeks of treatment.
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EU Clinical Trial 2009-013235-38 – EMA – Mar 25, 2010

A multicenter, randomized, double-blind, placebocontrolled study, to assess the long term safety of 52 weeks treatment with QVA149 (110μg indacaterol / 50μg glycopyrrolate) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Main objective of the trial: To assess the safety/tolerability of 52 weeks of treatment with QVA149 (110μg indacaterol/50μg glycopyrrolate) once a day on adverse event reporting rate in patients with moderate or severe Chronic Obstructive Pulmonary D...
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EU Clinical Trial 2009-015508-24 – EMA – Feb 15, 2010

A 38-week extension to a 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis (ENDURE Study)

Main objective of the trial: To evaluate the efficacy of continuous treatment with subcutaneous AIN457 compared to placebo for maintaining the suppression of intraocular inflammation and the prevention of an active intermediate, posterior or panuveit...
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EU Clinical Trial 2009-016604-23 – EMA – May 3, 2010

A multi-center, double-blind, placebo-controlled, randomized study to compare the effect of a subcutaneous canakinumab administration to placebo in patients with Impaired Glucose Tolerance or patients with Type 2 Diabetes treated with differing baseline diabetes therapies.

Main objective of the trial: The primary objective is to evaluate canakinumab effects on change from baseline of meal challenge derived insulin secretion rate relative to glucose 0-2 hours (Φd), at 4 weeks, on the following populations: a. patients w...
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EU Clinical Trial 2009-012600-48 – EMA – Oct 21, 2009

A randomized, partially-blinded, single-dose, 4-way crossover study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Concept1 device or as a PulmoSphere® formulation via the Simoon device

Main objective of the trial: To assess the bronchodilator effect of an orally inhaled indacaterol maleate PulmoSphere® formulation in patients with persistent asthma compared with placebo as measured by mean change in FEV1 from baseline to post-dose...
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EU Clinical Trial 2011-000960-93 – EMA – May 10, 2012

A 12-week treatment, randomized, blinded, double-dummy, parallel-group study to assess the efficacy, safety, and tolerability of NVA237 (50 μg o.d.) compared to tiotropium (18 μg o.d.) in patients with chronic obstructive pulmonary disease (COPD)

Main objective of the trial: To demonstrate non-inferiority of NVA237 50 μg o.d. versus tiotropium 18 μg o.d. with respect to trough Forced Expiratory Volume in one second (trough FEV1) after 12 weeks (84 days) of treatment in patients with moderate...
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EU Clinical Trial 2006-004586-34 – EMA – Jan 23, 2007

A A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone

Main objective of the trial: ユ To confirm that the combination of valsartan/amlodipine 160/5mg is non-inferior to amlodipine 10mg alone when comparing the reduction of MSSBP from baseline to week 8 (Visit 4) between the two treatment groups. ユ To con...
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EU Clinical Trial 2006-006126-25 – EMA – Jun 8, 2007

Emotional and Social deficits in Asperger syndrome

Main objective of the trial: This project aims to study the possibility of having an enhancement in the social life of Asperger patients. We will study the effect of syntocinon spray on major fields wich caractarize the bases of any social interactio...
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EU Clinical Trial 2014-004696-24 – EMA – Feb 29, 2016

Breakthrough pain incidence in pregnant women comparing two Epidural analgesia shemes added to a continuous infusion (bowling planned indicators and analgesia epidural patient controlled): double-blind randomized

Main objective of the trial: Evaluate the incidence of breakthrough pain in pregnant women who received epidural analgesia along dilation under two different analgesic regimens Evaluar la incidencia de dolor irruptivo en parturientas que hayan recibi...
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EU Clinical Trial 2015-005314-29 – EMA – Mar 2, 2016

Randomized, open-label, two parallel group clinical trial, conducted under blinding evaluator conditions to compare the efficacy and tolerability of preservative-free formulation of Latanoprost 50µg/ml eye drops vs. Xalatan in patients with open-angle glaucoma or hypertension ocular.

Main objective of the trial: It is the objective of the clinical trial to confirm the clinical non-inferiority of the preservative-free latanoprost eye drops compared with the marketed preservative-containing Xalatan? by the average decrease of diurn...
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EU Clinical Trial 2013-000721-31 – EMA – May 7, 2013

Comparison of neuromuscular blockade’s monitoring and clinical assessment during cisatracurium paralysis in critically ill patients

Main objective of the trial: To discover if neuromuscular blockade monitoring by TOF compared with clinical assessment during cisatracurium paralysis reduces the incidence of pharmacological overdose.
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EU Clinical Trial 2015-000284-14 – EMA – Jan 5, 2016

Assessment of Metoprolol in the Prevention of Vasovagal Syncope in Aging Subjects

Main objective of the trial: Will Metoprolol reduces the time to a first recurrence of syncope(fainting) in patients ≥40 years old who have a high likelihood of recurrent vasovagal syncope( fainting).
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EU Clinical Trial 2014-000095-26 – EMA – Jul 11, 2014

A randomised, parallel-group, open-label Phase II trial of the immunological effects of three regimens of GX301 vaccination in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line chemotherapy.

Main objective of the trial: To compare three different GX301 administration regimens in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line docetaxel, for the following co-primary outcomes: ?...
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EU Clinical Trial 2008-001718-26 – EMA – May 7, 2010

An eight-week, multicenter, randomized, double-blind, placebo-controlled dose-finding study, with escitalopram (10mg daily) as active control, to evaluate the efficacy, safety and tolerability of three fixed doses of SSR411298 (10, 50, or 200mg daily) in elderly patients with Major Depressive Disorder

Main objective of the trial: The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Ha...
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EU Clinical Trial 2015-005542-56 – EMA – Apr 29, 2016

Effects of anti-TSLP on airway hyperresponsiveness and mast cell phenotype in asthma - A randomized double-blind, placebo-controlled trial of MEDI9929 The UPSTREAM study

Main objective of the trial: To investigate whether airway hyperresponsiveness to mannitol decreases in response to treatment with MEDI9929 in patients with asthma
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EU Clinical Trial 2005-001613-17 – EMA – Feb 27, 2006

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed- Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled with Insulin

Main objective of the trial: To assess the effect of rimonabant on HbA1c in patients with type 2 diabetes treated with insulin.
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EU Clinical Trial 2007-006935-29 – EMA – Jun 12, 2008

A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Main objective of the trial: • To show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function
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EU Clinical Trial 2006-001452-12 – EMA – Apr 4, 2007

An open-label, non-controlled multicentre trial to evaluate the insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator

Main objective of the trial: To evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant.
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EU Clinical Trial 2006-002317-12 – EMA – Aug 29, 2006

A double-blind placebo-controlled study of the activity of AVE1625 at doses of 10 mg and 40mg for 12 weeks in patients with mild to moderate Alzheimer's Disease

Main objective of the trial: To assess the activity of AVE1625 at the doses of 10 and 40 mg/day in comparison to placebo in patients with mild to moderate Alzheimer Disease: - Safety and tolerability by monitoring of adverse events, clinical laborato...
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EU Clinical Trial 2008-003824-51 – EMA – Aug 14, 2009

A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming.

Main objective of the trial: Immunogenicity Persistence At 24, 36, and 48 months after primary vaccination of toddlers with MenACWY-TT or Meningitec •To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with...
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EU Clinical Trial 2008-003741-87 – EMA – Apr 2, 2009

A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age

Main objective of the trial: •To demonstrate that GSK Biologicals’ DTPa IPV/Hib-MenC-TT vaccine co-administered with Prevenar (MenC-Combo group) is non-inferior to Pediacel co-administered with Prevenar and Menjugate (Control group), in terms of immu...
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EU Clinical Trial 2015-004133-27 – EMA – Apr 18, 2016

A randomized non-inferiority trial of hypoxia-profile guided hypoxic modification with nimorazole during radiotherapy/chemoradiotherapy of squamous cell carcinoma of the head and neck

Main objective of the trial: To show whether a hypoxic gene profile can classify patients that will have no effect of hypoxic modification with nimorazole during radiotherapy At eftervise, hvorvidt hypoxi gen-profilen kan udpege patienter som skønnes...
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EU Clinical Trial 2009-014916-37 – EMA – Mar 15, 2010

"Estudio de fase 4, doble ciego, controlado con placebo, multicéntrico y de 12 semanas de duración para evaluar la seguridad y la eficacia del tartrato de Vareniclina (CP-526,555) 1 mg dos veces al día para dejar de fumar en pacientes con depresión" "A PHASE 4 12-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF VARENICLINE TARTRATE (CP-526,555) 1MG BID FOR SMOKING CESSATION IN SUBJECTS WITH DEPRESSION"

Main objective of the trial: Compare 12 weeks of varenicline treatment to placebo for end of treatment smoking cessation efficacy in smokers with depression.
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EU Clinical Trial 2005-004250-28 – EMA – Sep 22, 2006

A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAM OR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS

Main objective of the trial: To compare the safety and efficacy of tigecycline to that of the comparator in treating subjects with complicated skin and skin structure infection (cSSSI).
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EU Clinical Trial 2012-003973-24 – EMA – Jan 22, 2013

A Multicenter Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily with Tiotropium 18 mcg Once Daily over 24 Weeks in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Main objective of the trial: The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 24 weeks for the treatment of subjects with COPD.
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EU Clinical Trial 2011-001900-36 – EMA – Sep 26, 2011

FFA115285: A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids.

Main objective of the trial: To evaluate the efficacy and safety of inhaled fluticasone furoate 50 mcg administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 24-week treatment p...
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EU Clinical Trial 2010-021490-37 – EMA – Mar 9, 2011

A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.

Main objective of the trial: 1. To evaluate the immunogenicity of PR5I when given at 2, 3, 4, and 12 months. 2. To compare the immunogenicity response elicited by PR5I to that of INFANRIX hexa when given at 2, 3, 4, and 12 months.
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EU Clinical Trial 2007-005168-29 – EMA – Aug 13, 2008

An Open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age with either HEXAVAC or INFANRIX-HEXA

Main objective of the trial: Immunogenicity To describe in subjects vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL (i.e. se...
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EU Clinical Trial 2006-000556-41 – EMA – Dec 5, 2006

An open, phase IV, single-group multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in children at 4-5 years of age, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine.

Main objective of the trial: To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects at 4-5 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life.
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EU Clinical Trial 2010-021491-28 – EMA – Jan 26, 2012

A phase III randomized, double-blind, active-comparator controlled clinical trial to study the safety, tolerability, and immunogenicity of V419 in healthy infants when given at 2, 4, and 11 to 12 months

Main objective of the trial: To evaluate the immunogenicity of PR5I when given at 2, 4, and 11 to 12 months of age.
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EU Clinical Trial 2011-005060-26 – EMA – Jun 19, 2012

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Activecontrolled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlledrelease Tablets (OXY)) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy

Main objective of the trial: To assess the analgesic efficacy of OXN compared to placebo in opioidexperienced subjects with moderate to severe low back pain and opioidinduced constipation who require around-the-clock opioid therapy To assess the effi...
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EU Clinical Trial 2015-000301-40 – EMA – Mar 11, 2016

A randomised, blinded, placebo-controlled Phase 2a study to evaluate the safety and efficacy of Artesunate treatment in severely injured trauma patients with traumatic haemorrhage.

Main objective of the trial: To determine whether Artesunate is safe and effective in treating severely-injured patients with traumatic haemorrhage in addition to the current standard management.
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EU Clinical Trial 2008-007334-22 – EMA – Nov 2, 2009

A randomized, double-blind, double-dummy, 2-arm parallel-group, multicenter 24-week study comparing the efficacy and safety of AVE0010 to sitagliptin as add-on to metformin in obese type 2 diabetic patients younger than 50 and not adequately controlled with metformin.

Main objective of the trial: To assess the efficacy of AVE0010 on a composite endpoint of glycemic control (HbA1c) and body weight in comparison to sitagliptin as an add-on treatment to metformin over a period of 24 weeks in obese type 2 diabetic pat...
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