Comparison of the ED95 dose of 0.075% and 0.1% bupivacaine for labour analgesia in primigravida
Main objective of the trial: What is the dose of bupivacaine 0.075% and bupivacaine 0.1% that has 95% chance of success for epidural pain relief, during early part of labour, for a woman having first child.
A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy
Main objective of the trial: To determine if LY2495655 administered in combination with chemotherapy improves overall survival (OS), compared to chemotherapy in combination with placebo in patients with Stage II-IV unresectable pancreatic cancer
A phase III randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection
Main objective of the trial: The objective of Cohort A is to evaluate the safety and pharmacokinetic (PK) profile of BI 207127 (potentially two doses) in combination with 120 mg once daily (q.d.) FDV and weight-based RBV in a small group of patients...
A Single Centre Study Investigating the Safety and Efficacy of an Immune Modulation Regimen in Mitigating the Alloimmune Response to Intravenous Laronidase in Infants With Severe Mucopolysaccharidosis type I (Hurler syndrome) Prior to Haematopoietic Stem Cell Transplantation
Main objective of the trial: The objective of this trial is to investigate the safety and efficacy of methotrexate as an immune tolerance induction agent in mitigating the alloimmune response to enzyme replacement therapy with laronidase in severe MP...
A Phase 3 Evaluation of Daclatasvir in Combination with Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination with Peginterferon Alfa-2a and RBV in Patients with Chronic Hepatitis C Genotype 1b who are Treatment Naïve or Prior Relapsers to Alfa/RBV Therapy (The STRUCTURE Study) Revised Protocol 03, incorporating Amendment 09 (version 1.0, dated 09-Jul-2013) + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 21-Jun-12)
Main objective of the trial: To compare the efficacy of Lambda/RBV/DCV to alfa-2a/RBV/TVR in subjects with chronic infection with HCV GT-1b, measured as the proportion of subjects who achieve SVR12 at post-treatment follow-up Week 12.
A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH TELAPREVIR AND PEGASYS/COPEGUS COMPARED WITH TELAPREVIR AND PEGASYS/COPEGUS IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN.
Main objective of the trial: To estimate the difference in sustained virologic response 12 weeks after treatment (SVR-12) between each of the following three experimental treatment groups (regimens containing RO5024048, telaprevir, Pegasys, and Copeg...
A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients
Main objective of the trial: To evaluate the non-inferiority of EVG/COBI/FTC/TDF relative to regimens consisting of a NNRTI plus FTC/TDF in maintaining HIV 1 RNA < 50 copies/mL at Week 48 (Snapshot Analysis) in virologically suppressed, HIV 1 infecte...
A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men.
Main objective of the trial: The primary objective of the double blind phase is to compare the effect of testosterone solution vs. placebo on the proportion of hypogonadal men having a serum total testosterone concentration within the normal range (3...
Comparative efficacy of DUODART tm plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naive men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.
Main objective of the trial: To assess the efficacy of DUODART treatment plus lifestyle advice in providing superior symptomatic improvement to treatment na�ve BPH subjects compared with watchful waiting plus lifestyle advice plus step-up therapy wit...
A multi center, randomized, double blind, placebo-controlled, study of the safety, tolerability, and the effects on arterial structure and function of ACZ885 in patients with clinically evident atherosclerosis and either type 2 diabetes mellitus(T2DM) or impaired glucose tolerance(IGT)
Main objective of the trial: -To assess the safety and tolerability of monthly sc administration of ACZ885 in patients with atherosclerosis and type 2 diabetes mellitus (T2DM) or impaired glucose tolerance (IGT) -To assess the effect of ACZ885 on aor...
BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving RO5185426 or Dacarbazine.
Main objective of the trial: To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E mutation
A Multicenter, Randomized, Double-Blind, “Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.
Main objective of the trial: Evaluate the LDL-C-lowering effects and evaluate the HDL-C-raising effects of MK-0524B combination tablet versus coadministered MK-0524A and Simvastatin.
A Phase II/II Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer
Main objective of the trial: 1. To determine overall survival of patients with metastatic colorectal cancer expressing the wtKRAS genotype treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab...
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined with Dasatinib to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer Revised Protocol 03 incorporating Administrative Letter(s) 02 and Amendment(s) 05 + Protocol Amendment 01 (v1.0, date 20-Jun-2008)
Main objective of the trial: The primary objective is to compare overall survival for dasatinib plus docetaxel and prednisone versus placebo plus docetaxel and prednisone in subjects with metastatic castration-resistant prostate cancer.
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Sorafenib versus Sorafenib Alone as First Line Therapy in Patients with Hepatocellular Carcinoma
Main objective of the trial: Phase Ib: To determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with sorafenib in patients with locally advanced or metastatic hepatocellular c...
A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF MEHD7945A VERSUS CETUXIMAB IN PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE PROGRESSED DURING OR FOLLOWING PLATINUM BASED CHEMOTHERAPY
Main objective of the trial: The main objective is to evaluate the efficacy of MEHD7945A (administered every 2 weeks) versus cetuximab (administered weekly) in all and in biomarker positive patients with recurrent/metastatic squamous cell carcinoma o...
A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care
Main objective of the trial: To investigate the safety and tolerability of multiple doses of ALX-0171
A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia. Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de 12 semanas para evaluar la eficacia y la seguridad de niacina de liberación prolongada (LP)/laropiprant añadidos a una estatina en comparación con la duplicación de la dosis de la estatina en pacientes con hipercolesterolemia primaria o dislipidemia mixta
Main objective of the trial: To evaluate the LDL-C lowering efficacy of the addition of ER niacin/laropiprant to simvastatin or atorvastatin (pooled) compared with doubling the dose of simvastatin or atorvastatin (pooled) in patients with primary hyp...
A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)
Main objective of the trial: Primary Efficacy Objective: The Primary Efficacy Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson’s disease (PD) as measured by the...
An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy.
Main objective of the trial: The ‘run-in part’ primary objective: • To determine a safe light dose for PC-A11 with interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiot...
A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active psoriatic arthritis
Main objective of the trial: To demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response.
A multi-center, randomized, parallel group, comparative, active controlled, safety-assessor blinded, phase IIIa, pivotal trial, in adult subjects comparing Org 25969 with neostigmine as reversal agent of a neuromuscular block induced by rocuronium or vecuronium at reappearance of T2.
Main objective of the trial: • To demonstrate faster recovery from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 mg.kg-1 Org 25969 compared to 50 µg.kg-1 neostigmine. • To demonstrate faster recovery from a n...
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3
Main objective of the trial: The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
A double-blind, cross-over patient preference study of frovatriptan versus zolmitriptan for the acute treatment of migraine
Main objective of the trial: The primary objective of this study is to evaluate the subjective existence and strength of the patient’s preference for either study medication after having tested both of them on a number of between 1 and 3 attacks of m...
Does metformin improve pregnancy outcomes [ incidence of LGA (≥90% birth weight centile) babies onset of maternal Gestational Diabetes, hypertension, PET, shoulder dystocia, admission to SCBU) in obese non-diabetic women?
Main objective of the trial: There is substantial evidence that obesity in pregnancy contributes to increased morbidity and mortality for both mother and baby. The purpose of the study is whether management of obese non-diabetic pregnant women with s...
A randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination with Tarceva® (erlotinib) in Patients with Met Diagnostic-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Standard Chemotherapy for Advanced or Metastatic Disease
Main objective of the trial: The primary objective of this study is to determine whether the combination of onartuzumab + erlotinib is superior (in terms of OS) to placebo + erlotinib after standard platinum-based chemotherapy in patients with Met di...
A randomized, multicenter, adaptive phase II/III study to evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) versus taxane (docetaxel or paclitaxel) in patients with previously treated locally advanced or metastatic HER2-positive gastric cancer, including adenocarcinoma of the gastroesophageal junction.
Main objective of the trial: To compare the overall survival (OS) of patients treated with trastuzumab emtansine with the regimen from Stage 1 of the study selected at the interim analysis to the OS of patients treated with physician’s choice of taxa...
Safety and efficacy of fixed dose combination of Indapamide SR 1.5 mg / Amlodipine versus Valsartan / Amlodipine over 12-week of treatment with conditional titration based on the blood pressure control, in patients with uncontrolled essential hypertension after 1 month of Amlodipine 5 mg run-in treatment. An international, randomized, double-blind, multicenter controlled study.
Main objective of the trial: To demonstrate better efficacy of fixed-dose combination strategy Indapamide SR 1.5 mg/Amlodipine versus Valsartan/Amlodipine fixed-dose in lowering office systolic blood pressure at W12.
A multi-centre, randomised, single-blind, placebo-controlled, parallel group study to investigate the efficacy of single pre-emptive doses of GW842166X, a non-cannabinoid CB2 receptor agonist, on pain following third molar tooth extraction.
Main objective of the trial: To evaluate the analgesic efficacy of pre-emptive doses of GW842166 administered in two dose levels following dental surgery
A randomized, double-blind, parallel group, 52-week study evaluating the efficacy, safety and tolerability of NVA237 in patients with poorly controlled asthma
Main objective of the trial: To demonstrate the superiority of NVA237 50 μg o.d. compared to placebo in addition to background therapy with LABA/ ICS (≥ 800 μg/day of budesonide or equivalent) in terms of trough FEV1 (the mean of values 23h 15min and...
A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and efficacy in subjects with moderate to severe plaque psoriasis
Main objective of the trial: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16
A retrospective study to compare the 3-year antiviral efficacy of nevirapine and efavirenz in combination with D4T and 3TC in 2NN patients
Main objective of the trial: The primary objective of the trial is to determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between nevirapine (twice daily) and efavirenz.
Long-term, open-label, multicenter study assessing long-term cardiovascular risks in patients treated with fingolimod
Main objective of the trial: To estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation, as defined by the incidence of selected cardiovascular events over the course of...
A randomised crossover investigation to evaluate and compare the effectiveness, safety and feasibility of a novel dedicated Over-The-Wire FFR Infusion MicroCatheter (HYPEREM IC) for measuring fractional flow reserve (FFR) using intra-coronary non-weight adjusted adenosine infusion with the standard intra-venous administration of adenosine, in subjects with intermediate coronary artery stenosis
Main objective of the trial: The main objective is to demonstrate the use of the investigation device using intra coronary adenosine infusion results in non-inferior FFR measurements when assessing intermediate stenoses, when compared to the standard...
A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
Main objective of the trial: To evaluate and compare the OS of subjects with advanced or metastatic HER2 negative breast cancer when treated with ruxolitinib in combination with capecitabine versus capecitabine alone.
A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients.
Main objective of the trial: To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) β-1a (Avonex®) in reducing the rate of clinical relapses in patients with RMS.
A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients with Later-onset Spinal Muscular Atrophy
Main objective of the trial: To examine the clinical efficacy of ISIS 396443 administered intrathecally to patients with later-onset SMA. Valutare l'efficacia di ISIS 396443 somministrato per via intratecale a pazienti con SMA ad esordio tardivo
A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis
Main objective of the trial: To demonstrate that at least one dose regimen of BYM338 will increase the 6 minute walking distance test relative to placebo at week 52.
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia(VALOR)
Main objective of the trial: Compare overall survival (OS) between treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine
A PHASE III, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS
Main objective of the trial: To compare the efficacy and the safety of the standard Rd schedule (arm A) versus an experimental approach including the standard Rd regimen as induction, followed by lenalidomide alone as maintenance (arm B). Comparare l...
A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
Main objective of the trial: The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator’s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue...
A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension
Main objective of the trial: Main objective of the trial is to characterize the pharmacokinetics (PK) of tadalafil in a pediatric population with pulmonary arterial hypertension (PAH) to establish an appropriate dose range for further clinical resear...
A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia A (FVIII:C <1%)
Main objective of the trial: To evaluate the pharmacokinetics and incremental recovery of ReFacto AF in pediatic subjects less than 12 years of age after a single exposure to ReFacto AF.