Clinical trials: Patient Safety
Essential Hypertension
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
- Trial name
- NCT00857285
- Testing
- olmesartan medoxomil, losartan potassium
- Where
- 3 sites in Taiwan
- Volunteers
- 130 people
- Sponsor
- Daiichi Sankyo
Renal Cell Carcinoma
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated…
- Trial name
- CheckMate 374 (NCT02596035)
- Testing
- Nivolumab
- Where
- 39 sites in United States
- Volunteers
- 197 people
- Sponsor
- Bristol-Myers Squibb
Idiopathic Restless Legs Syndrome
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS.
- Trial name
- NCT00390689
- Testing
- Pramipexole 0.125 mg tablet, Pramipexole 0.5 mg tablet
- Where
- 34 sites in Japan
- Volunteers
- 154 people
- Sponsor
- Boehringer Ingelheim
Hereditary Periodic Fevers
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.
- Trial name
- NCT02059291
- Testing
- Canakinumab
- Where
- 65 sites in United States, Belgium and 14 more
- Volunteers
- 203 people
- Sponsor
- Novartis Pharmaceuticals
Short Bowel Syndrome
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
- Trial name
- EASE SBS 1 (NCT03690206)
- Testing
- glepaglutide
- Where
- 29 sites in United States, Belgium and 7 more
- Volunteers
- 106 people
- Sponsor
- Zealand Pharma
Pain, Cancer
Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy.
- Trial name
- NCT00293033
- Testing
- BEMA™
- Where
- United States
- Volunteers
- 152 people
- Sponsor
- BioDelivery Sciences International
Nasal Polyposis, Eosinophilic Chronic Rhinosinusitis
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus…
- Trial name
- ORCHID (NCT04157335)
- Testing
- Benralizumab 30 mg
- Where
- 116 sites in United States, Argentina and 15 more
- Volunteers
- 295 people
- Sponsor
- AstraZeneca
Erosive Esophagitis
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment…
- Trial name
- NCT02679508
- Testing
- Vonoprazan, Lansoprazole
- Where
- 36 sites in Japan
- Volunteers
- 208 people
- Sponsor
- Takeda
Acute Pain
A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery
This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients…
- Trial name
- NCT01789476
- Testing
- CR845
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Cara Therapeutics, Inc.
Diarrhea-predominant Irritable Bowel Syndrome
Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
This study is being conducted to evaluate in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment and to evaluate the overall safety and…
- Trial name
- NCT03977155
- Testing
- BOS-589
- Where
- 58 sites in United States
- Volunteers
- 133 people
- Sponsor
- Boston Pharmaceuticals
Post-surgical Pain
Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs.
- Trial name
- NCT03599089
- Testing
- CA-008, Ketorolac, Acetaminophen
- Where
- 3 sites in United States
- Volunteers
- 147 people
- Sponsor
- Concentric Analgesics
Type 1 Diabetes Mellitus
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes…
- Trial name
- NCT02688933
- Testing
- HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml), Mandated back ground therapy
- Where
- 100 sites in United States, Puerto Rico
- Volunteers
- 638 people
- Sponsor
- Sanofi
Atopic Dermatitis
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy
- Trial name
- NCT01986933
- Testing
- nemolizumab (CIM331)
- Where
- 18 sites in United States
- Volunteers
- 264 people
- Sponsor
- Chugai Pharmaceutical
Parkinson Disease, Cognitive Impairment
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease.
- Trial name
- NCT03204526
- Testing
- deep brain stimulation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of California, Davis
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-2 (NCT03656926)
- Testing
- Liposomal Cyclosporine A, Standard of Care
- Where
- 40 sites in United States, Austria and 7 more
- Volunteers
- 169 people
- Sponsor
- Zambon SpA
Postoperative Pain
OxyNorm Capsules in Post-Operative Pain Study
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
- Trial name
- NCT01675635
- Testing
- OxyNorm Capsules, Morphine tablet
- Volunteers
- 240 people
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Type 1 Diabetes Mellitus
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥…
- Trial name
- NCT02582840
- Testing
- Dapagliflozin 5mg, Dapagliflozin 10mg
- Where
- Japan
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
Transthyretin Familial Amyloid Polyneuropathy
The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin
Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
- Trial name
- NCT01435655
- Testing
- tafamidis
- Where
- 2 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Pfizer
Hemophilia B
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown…
- Trial name
- NCT00484185
- Testing
- BeneFIX (coagulation factor IX (recombinant))
- Where
- South Korea
- Volunteers
- 183 people
- Sponsor
- Pfizer
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