Searching for keyword:"Drug therapy"

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US Clinical Trial NCT01945216 – NIH – Sep 13, 2013

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions. Participants of this surveillance will be patients with...
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US Clinical Trial NCT03449030 – NIH – Feb 22, 2018

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients With Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C

The drug being tested in this study is a novel antibody-drug conjugate (ADC) called TAK-164. TAK-164 is being evaluated in participants with advanced GCC-positive GI cancer (Part A) or CRC (Part B) to determine safety, tolerability, and pharmacokine...
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US Clinical Trial NCT00249912 – NIH – Nov 4, 2005

A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg, 100 mg or Placebo When Coadministered With Rosuvastatin 10 mg or 20 mg in Subjects With Primary Hypercholesterolemia

Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances (dyslipidemias) are major risk factors for coronary heart disease. Patients with hypercholesterolemia have elevated low-density lipoprotein cholesterol, whi...
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US Clinical Trial NCT00629876 – NIH – Feb 26, 2008

A Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple Hematide Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who Are Anemic and Receiving Cytotoxic Chemotherapy

Currently approved erythropoiesis stimulating agents have been used successfully to increase hemoglobin levels, reduce fatigue and other anemia-related symptoms, improve daily function, and alleviate the need for transfusions of red blood cells in s...
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US Clinical Trial NCT00631631 – NIH – Feb 29, 2008

Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma

The drug being tested in this study is called mifamurtide (L-MTP-PE; liposomal muramyl tripeptide phosphatidyl ethanolamine). Mifamurtide is being used to treat people with osteosarcoma, a form of cancer. This was a patient-access study that looked...
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US Clinical Trial NCT02068495 – NIH – Feb 19, 2014

Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine cl...
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US Clinical Trial NCT02451150 – NIH – May 19, 2015

An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics Following a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

The drug being tested in this study is called azilsartan. Azilsartan was being tested to evaluate how it is processed by the body (pharmacokinetics). This study looked at lab results in pediatric participants who took azilsartan. The study enrolled...
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US Clinical Trial NCT02193087 – NIH – Jul 15, 2014

A Randomized, Double Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Adults

The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). This study is designed to determine whether the lyophilized formulation provides equivalent safety and immunogenicity as the original liquid formulation....
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US Clinical Trial NCT02202785 – NIH – Jul 7, 2014

A Phase 2 Trial of MLN0264 in Previously Treated Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C (GCC)

The drug being tested in this study is called MLN0264. MLN0264 is being tested to treat tumors in people who have metastatic adenocarcinoma of the pancreas expressing guanylyl cyclase C (GCC). This study will assess tumor size reduction in patients...
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US Clinical Trial NCT01964950 – NIH – Oct 15, 2013

Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants w...
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US Clinical Trial NCT02162758 – NIH – Jun 10, 2014

A Randomized, Double-Blind, Phase 4 Study to Evaluate the Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have...
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US Clinical Trial NCT02302066 – NIH – Nov 24, 2014

A Phase II, Double-Blind, Controlled Trial to Assess the Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Subjects Aged Between 2 and <18 Years and Living in Dengue Endemic Countries in Asia and Latin America

The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to assess how different dosing schedules of the vaccine effect immunity to dengue fever in dengue endemic countries. This study will l...
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US Clinical Trial NCT02312258 – NIH – Dec 5, 2014

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow PD and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. Th...
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US Clinical Trial NCT01299805 – NIH – Feb 17, 2011

A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Effects of Oral Administration of Lu AA21004 20 mg on the Concentrations of Selected Neurotransmitters in Healthy Male Subjects

This study will look at an investigational medicine called vortioxetine to see how the drug affects the body and how the body handles the drug. The study enrolled 17 patients. Participants were randomly assigned at a 2:1 ratio to one of the followi...
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US Clinical Trial NCT00817739 – NIH – Jan 5, 2009

Intermittent Hormonal Therapy With Leuprorelin (3.75 mg SR) and Flutamide in the Treatment of Stage D2 or Tx Nx M1 ≠ M1a Metastatic Cancer of the Prostate

This is an open, comparative, randomized (1:1), multicenter, European (France, Germany, Czech Republic, Slovakia and Bulgaria), Phase 2B study on parallel groups of patients presenting with metastatic prostate cancer (stage D2 or Tx Nx M1 ≠ M1a), wi...
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US Clinical Trial NCT01428323 – NIH – Sep 1, 2011

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US Clinical Trial NCT01433393 – NIH – Sep 12, 2011

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US Clinical Trial NCT01433419 – NIH – Sep 12, 2011

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US Clinical Trial NCT01452711 – NIH – Sep 16, 2011

A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Gastric Ulcer.

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US Clinical Trial NCT01765192 – NIH – Jan 8, 2013

A Phase 2, Randomized, Double-Blind, 4-week Crossover Trial to Investigate the Effect of a Once-Daily Combination of 500 µg Roflumilast Plus 10 mg Montelukast vs 10 mg Montelukast Alone on Pulmonary Function, Asthma Symptoms, and Inflammatory Markers in Subjects With Severe Asthma Not Adequately Controlled With a Combination of at Least Medium Dose Inhaled Corticosteroids and Long-Acting Beta Agonists Maintenance Therapy

The drug being tested in this study is called roflumilast. Roflumilast is being tested to treat people who have asthma. This study will look at lung function and asthma symptoms of people who take roflumilast in combination with montelukast.
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US Clinical Trial NCT02504320 – NIH – Jul 20, 2015

A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations

The drug being tested is this study is febuxostat XR. Four different formulations of febuxostat XR are being tested to see how the drug moves through the body. This study will look at safety and side effects in people who take febuxostat XR. This c...
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US Clinical Trial NCT02480764 – NIH – Jun 22, 2015

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Chinese Subjects With Essential Hypertension

The drug being tested in this study is called TAK-491 (azilsartan medoxomil). Azilsartan medoxomil is being tested to treat Chinese people who have essential hypertension. This study will look at change in blood pressure after 8 weeks of treatment i...
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US Clinical Trial NCT02948829 – NIH – Oct 26, 2016

An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years

The vaccine being tested in this study is TDV. This study will look at cellular immune responses following TDV vaccination in dengue endemic regions. The study will enroll approximately 200 participants. Participants will receive: • TDV 0.5 mL sub...
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US Clinical Trial NCT03535649 – NIH – May 14, 2018

Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study

This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility per...
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US Clinical Trial NCT03648372 – NIH – Aug 24, 2018

An Open Label, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TAK-981 in Adult Patients With Metastatic Solid Tumors or Lymphomas

The drug being tested in this study is called TAK-981. TAK-981 is being tested to evaluate safety, tolerability, and PK in participants who have locally advanced or metastatic solid tumors or relapsed or refractory lymphomas for whom there is no sta...
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US Clinical Trial NCT03870555 – NIH – Mar 4, 2019

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, 3-Period, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-954 in Healthy Adult Participants

The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied. The study will enroll approximately 6 participants...
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US Clinical Trial NCT03928327 – NIH – Apr 24, 2019

A Phase 1 Study of Oral TAK-788 to Evaluate the Drug-Drug Interaction With Itraconazole and Rifampin in Healthy Adult Subjects

The drug being tested in this study is called TAK-788. The study will assess the drug-drug interaction of TAK-788 with either a strong cytochrome P-450 (CYP)3A inhibitor, itraconazole (Part 1) or with a strong CYP3A inducer, rifampin (Part 2) in hea...
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US Clinical Trial NCT03434977 – NIH – Feb 8, 2018

A Randomized, Open-Label, Cross-over Phase 1 Study to Evaluate the Food Effect of Single Oral Dose of TAK-536 Pediatric Formulation in Healthy Adult Male Subjects

The drug being tested in this study is called TAK-536. TAK-536 is being tested in Japanese healthy adult male participants. This study will look at the PK and effect of food on the PK following single oral administration of TAK-536 pediatric formula...
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US Clinical Trial NCT03748953 – NIH – Nov 16, 2018

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

The drug being tested in this study is called ixazomib. Ixazomib is being tested to slow disease progression and improve overall survival in Chinese participants who have newly diagnosed multiple myeloma (NDMM) who have had a major positive response...
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US Clinical Trial NCT03359785 – NIH – Nov 27, 2017

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia

The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat people with schizophrenia. The study will enroll approximately 32 patients. Participants will be randomly assigned to one of the two treatment sequences which w...
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US Clinical Trial NCT02774902 – NIH – May 13, 2016

A Phase 1, Open-Label, Sequential Design Study to Evaluate the Effect of Multiple Oral Doses of Clarithromycin on the Pharmacokinetics of a Single Oral Dose of TAK-438

The drug being tested in this study is called TAK-438. TAK 438 is being tested to assess the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438. The study will enroll approximately 16 healthy adult male participants...
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US Clinical Trial NCT02756819 – NIH – Apr 27, 2016

International Multicentre, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Patients With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan

The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have hypertension. This study will look at the clinic systolic and diastolic blood pressure (SBP, DBP) in obese participants...
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US Clinical Trial NCT02723006 – NIH – Mar 25, 2016

An Open-Label, Phase 1b, Multi-Arm Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

The drugs being tested in this study are called TAK-580, TAK-202 (plozalizumab), and vedolizumab. These investigational drugs were given along with standard of care checkpoint inhibitors ([nivolumab in Arms 1 and 2] or nivolumab + ipilimumab in Arm...
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US Clinical Trial NCT02611817 – NIH – Nov 19, 2015

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

The drug being tested in this study is called vedolizumab SC. Vedolizumab SC is being tested to treat people who have moderate to severely active CD. This study will look at clinical remission, as well as enhanced clinical response and corticosteroi...
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US Clinical Trial NCT02611830 – NIH – Nov 19, 2015

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to treat people who have moderate to severely active ulcerative colitis. This study will look at clinical remission as well as mu...
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US Clinical Trial NCT02684396 – NIH – Feb 16, 2016

A Phase 1, Randomized, Double-Blind, Placebo- Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single Oral TAK-648 Doses in Healthy Subjects

This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy participants. The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), a...
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US Clinical Trial NCT03342898 – NIH – Nov 10, 2017

A Randomized, Observer-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of a Tetravalent Dengue Vaccine Candidate and a Yellow Fever YF-17D Vaccine Administered Concomitantly and Sequentially in Healthy Subjects Aged 18 to 60 Years in Non-Endemic Country(Ies)

The vaccine tested in this study is TDV. TDV with concomitant administration of yellow fever (YF-17D) vaccine will be tested to assess immunogenicity and safety in healthy participants in non-endemic area(s) for both dengue and YF. The study will e...
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US Clinical Trial NCT01011751 – NIH – Nov 3, 2009

Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma

Three drugs will be tested in this study: cyproterone acetate, medroxyprogesterone acetate and venlafaxine. Cyproterone acetate, medroxyprogesterone acetate and venlafaxine are being tested to treat men who suffer from hot flushes due to androgen su...
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US Clinical Trial NCT01217957 – NIH – Sep 24, 2010

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

The drug being tested in this study is called ixazomib. Ixazomib was being tested to treat people who had newly diagnosed multiple myeloma who had not previously received systemic treatment. This study was conducted in two Phases. Phase 1 looked at...
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US Clinical Trial NCT00853307 – NIH – Feb 26, 2009

A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients With Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. This study looked at...
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US Clinical Trial NCT00249899 – NIH – Nov 4, 2005

A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat or Placebo When Co-Administered With High Dose Statin Therapy in Subjects With Primary Hypercholesterolemia

Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances (dyslipidemias) are major risk factors for coronary heart disease. Patients with hypercholesterolemia have elevated low-density lipoprotein cholesterol, whi...
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US Clinical Trial NCT00256178 – NIH – Nov 16, 2005

A Placebo-controlled, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 50 mg and 100 mg Versus Placebo, When Co-administered With Simvastatin 20 mg or 40 mg in Subjects With Primary Dyslipidemia.

In humans, cholesterol is acquired from dietary sources and is produced de novo in the liver, intestine, and various other tissues. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy ch...
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US Clinical Trial NCT00268697 – NIH – Dec 20, 2005

A Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg and Lapaquistat Acetate 100 mg Administered in Combination With Ezetimibe 10 mg vs Ezetimibe 10 mg in Subjects With Primary Dyslipidemia

In humans, cholesterol is acquired from dietary sources and is produced de novo in the liver, intestine, and various other tissues. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy ch...
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US Clinical Trial NCT00532311 – NIH – Sep 18, 2007

A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg or Placebo When Co-administered With Statins in Subjects With Hypercholesterolemia, With an Optional Open-Label Extension

Dyslipidemias are a group of metabolic disorders produced by raised concentrations of lipoproteins, especially low-density lipoprotein cholesterol, which is the lipoprotein that transports endogenous cholesterol from the liver to the peripheral tiss...
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US Clinical Trial NCT00317031 – NIH – Apr 19, 2006

Individually Adapted Therapy of Alcoholism: Clinical Studies

The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics. The secondary objective is to establish an association between patients' motivational type and drug effects. The a...
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US Clinical Trial NCT01452685 – NIH – Aug 31, 2011

A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis

This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385...
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US Clinical Trial NCT01829464 – NIH – Apr 9, 2013

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral Fasiglifam 25 mg and 50 mg Compared to Placebo When Used in Combination With Sitagliptin in Subjects With Type 2 Diabetes

The drug being tested in this study is called TAK-875 (fasiglifam). Fasiglifam is being tested to treat people who have type 2 diabetes mellitus and are currently taking sitagliptin (with or without metformin). This study will evaluate glycemic cont...
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US Clinical Trial NCT01916304 – NIH – Aug 1, 2013

A Multicentre, Open-label Switch Study to Investigate the Necessity of Dose Adjustment After Switching From L-Thyroxine Christiaens® to the New Levothyroxine Sodium Test Formulation in (Near) Total Thyroidectomised Patients.

The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine...
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US Clinical Trial NCT02211638 – NIH – Mar 17, 2014

Blopress Tablets Special Drug Use Surveillance 「Challenge - Quality Control」

This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially...
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US Clinical Trial NCT02252354 – NIH – Sep 26, 2014

An Open-Label, Single-Centre,Two Part Phase I Mass Balance Study to Assess the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of Orally Administered [14C]-TAK-385 in Healthy Male Subjects

The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up to 6 participants will receive a single 80 mg dose of [14C]-TAK-385 administered as an oral solution. In Part 2, up to 6 participants will receive a single...
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