Clinical trials: Patient Safety
Eyelash Hypotrichosis
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
- Trial name
- NCT01391286
- Testing
- bimatoprost solution 0.03%, bimatoprost vehicle solution
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Allergan
B-Thalassemia
Study to Evaluate the Safety and Efficacy of Luspatercept (ACE-536) in Participants With Beta-thalassemia (A536-04/MK-6143-002)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics, of ascending doses of luspatercept in participants with β-thalassemia.
- Trial name
- NCT01749540
- Testing
- luspatercept
- Where
- 8 sites in Greece, Italy
- Volunteers
- 64 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Asthma
A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the…
- Trial name
- NCT01152450
- Testing
- Tiotropium 2.5 µg b.i.d, Tiotropium 5 µg q.d.
- Where
- 15 sites in Austria, Czechia and 3 more
- Volunteers
- 94 people
- Sponsor
- Boehringer Ingelheim
Prostate Cancer
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer.
- Trial name
- NCT02212197
- Testing
- leuprolide acetate FluidCrystal® injection depot, leuprolide acetate
- Where
- 7 sites in Finland, Hungary
- Volunteers
- 51 people
- Sponsor
- Camurus AB
Knee Osteoarthritis
Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.
- Trial name
- NCT01768520
- Testing
- Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks, Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks
- Where
- South Korea
- Volunteers
- 338 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks…
- Trial name
- PERFECT (NCT03496623)
- Testing
- Inhaled treprostinil solution
- Where
- 76 sites in United States, Argentina and 2 more
- Volunteers
- 188 people
- Sponsor
- United Therapeutics
Geographic Atrophy, Age-Related Macular Degeneration
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study…
- Trial name
- NCT05536297
- Testing
- avacincaptad pegol
- Where
- 117 sites in United States, Argentina and 15 more
- Volunteers
- 278 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Lipodystrophy, HIV Infections
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
- Trial name
- NCT00608023
- Testing
- Tesamorelin
- Where
- 47 sites in United States, Belgium and 4 more
- Volunteers
- 263 people
- Sponsor
- Theratechnologies
Agglutinin Disease, Cold
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the…
- Trial name
- NCT03347396
- Testing
- BIVV009
- Where
- 49 sites in United States, Australia and 12 more
- Volunteers
- 24 people
- Sponsor
- Bioverativ, a Sanofi company
Infection
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily…
- Trial name
- NCT00488488
- Testing
- tigecycline
- Volunteers
- 1,028 people
- Sponsor
- Pfizer
Moderate-to-Severe Atopic Dermatitis, Dermatitis, Dermatitis Atopic
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD).
- Conditions
- Moderate-to-Severe Atopic Dermatitis, Dermatitis, Dermatitis Atopic, Eczema, Skin Diseases, Skin, Diseases Genetic, Genetic
- Trial name
- NCT03054428
- Testing
- Dupilumab
- Where
- 45 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Regeneron Pharmaceuticals
Macular Degeneration
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm) respectively.
- Trial name
- T-REX (NCT01748292)
- Testing
- 0.5 mg ranibizumab
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Charles C Wykoff, PhD, MD
Osteoarthritis, Knee
A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee
A study to assess efficacy, safety, and tolerability of a single-dose intra-articular administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA).
- Trial name
- NCT04129944
- Testing
- UBX0101
- Where
- 20 sites in United States
- Volunteers
- 183 people
- Sponsor
- Unity Biotechnology, Inc.
Dyslipidemia
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
The primary purpose of your participation in this study is to help answer the following research question(s) Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat…
- Trial name
- NCT01105975
- Testing
- LY2484595, Atorvastatin, Simvastatin
- Where
- 59 sites in United States, Denmark and 4 more
- Volunteers
- 398 people
- Sponsor
- Eli Lilly and Company
Dry Eye Disease
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
- Trial name
- SIDE (NCT05411367)
- Testing
- SI-614
- Where
- 6 sites in United States
- Volunteers
- 232 people
- Sponsor
- Seikagaku Corporation
Relapsing-Remitting Multiple Sclerosis (RRMS)
MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)
This is a Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of…
- Trial name
- EMPhASIS (NCT03846219)
- Testing
- IMU-838 (30 mg/day), IMU-838 (45 mg/day), IMU-838 (10 mg/day)
- Where
- 38 sites in Bulgaria, Poland and 2 more
- Volunteers
- 210 people
- Sponsor
- Immunic AG
Nocturia Associated With Nocturnal Polyuria
Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with desmopressin…
- Trial name
- NCT00902265
- Testing
- desmopressin
- Where
- 140 sites in Germany
- Volunteers
- 138 people
- Sponsor
- Ferring Pharmaceuticals
Hypercholesterolemia
Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its active compound, pitavastatin has recently been approved by US FDA for indications of primary hypercholesterolemia and combined…
- Trial name
- NCT01710007
- Testing
- 1PC002, Lipitor
- Where
- 8 sites in Taiwan
- Volunteers
- 202 people
- Sponsor
- Orient Pharma Co., Ltd.
Chronic Obstructive Pulmonary Disease (COPD)
Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as…
- Trial name
- NCT01285492
- Testing
- QVA149, Tiotropium
- Where
- 35 sites in Japan
- Volunteers
- 160 people
- Sponsor
- Novartis Pharmaceuticals
Sepsis
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis.
- Trial name
- NCT03019965
- Testing
- Intermittent Piperacillin/tazobactam, Continuous Piperacillin/tazobactam, Intermittent Imipenem
- Where
- 2 sites in Mexico
- Volunteers
- 426 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
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