Clinical trials: Patient Safety
HIV Infections, Acquired Immunodeficiency Syndrome
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected…
- Trial name
- NCT00896051
- Testing
- Atazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 50 people
- Sponsor
- Janssen R&D Ireland
Hepatitis C
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy.
- Trial name
- PROMISE (NCT01281839)
- Testing
- TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
- Where
- 68 sites in United States, Australia and 11 more
- Volunteers
- 394 people
- Sponsor
- Janssen R&D Ireland
Uncontrolled Hypertension
DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
- Trial name
- NCT04248530
- Testing
- Renal denervation
- Where
- 5 sites in South Korea
- Volunteers
- 16 people
- Sponsor
- Kalos Medical
Obesity and Obesity-related Medical Conditions
An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)
A study to determine the safety and efficacy of an investigational drug in patients with obesity.
- Trial name
- NCT00131430
- Testing
- taranabant
- Volunteers
- 500 people
- Sponsor
- Merck Sharp & Dohme LLC
Age-related Macular Degeneration, Choroidal Neovascularization
Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD
This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration
- Trial name
- TREND (NCT01948830)
- Testing
- Ranibizumab 0.5mg
- Where
- 91 sites in Belgium, Chile and 17 more
- Volunteers
- 650 people
- Sponsor
- Novartis Pharmaceuticals
Age-Related Macular Degeneration
Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)
The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or…
- Trial name
- NCT00134667
- Testing
- Photodynamic Therapy (PDT) with Visudyne (verteporfin), Macugen (pegaptanib sodium)
- Where
- United States
- Volunteers
- 360 people
- Sponsor
- Eyetech Pharmaceuticals
Mixed Hyperlipidemia
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to…
- Trial name
- NCT00289900
- Testing
- MK-0524A, Atorvastatin, Simvastatin
- Volunteers
- 2,340 people
- Sponsor
- Merck Sharp & Dohme LLC
Muscle Tightness
Non-invasive Improvement of Buttocks With Magnetic Device
This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. The study is a prospective multi-center open-label single-arm study.
- Trial name
- NCT03575507
- Testing
- Treatment with BTL EMSCULPT device.
- Where
- 2 sites in United States, Bulgaria
- Volunteers
- healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Essential Thrombocythaemia
A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients
The primary objective of this study is to assess the efficacy of ropeginterferon alfa-2b in patients with ET who need cytoreductive treatment but are intolerant or refractory to, and/or ineligible for cytoreductive treatments…
- Trial name
- NCT06514807
- Testing
- Ropeginterferon alfa-2b (BESREMi®)
- Where
- 36 sites in Austria, Czechia and 8 more
- Volunteers
- 117 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
Type 2 Diabetes Mellitus
Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus
This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SY-009 after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT04345107
- Testing
- SY-009
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Candidiasis, Oral, HIV Infections
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients…
- Trial name
- NCT00002431
- Testing
- Chlorhexidine gluconate
- Where
- 5 sites in United States
- Sponsor
- Procter and Gamble
Diabetes Mellitus, Type 2
BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in…
- Trial name
- NCT00602472
- Testing
- linagliptin
- Where
- 100 sites in Argentina, Belgium and 9 more
- Volunteers
- 1,058 people
- Sponsor
- Boehringer Ingelheim
Hypercholesterolaemia
Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients
This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with…
- Trial name
- RESEARCH (NCT00695539)
- Where
- 6 sites in Greece
- Volunteers
- 810 people
- Sponsor
- AstraZeneca
Asthma
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320)…
- Trial name
- NCT02571777
- Testing
- QVM149 150/50/160, QVM149 150/50/80, QMF149 150/320
- Where
- 403 sites in Argentina, Austria and 39 more
- Volunteers
- 3,092 people
- Sponsor
- Novartis Pharmaceuticals
Primary Open-angle Glaucoma, Ocular Hypertension
A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients
TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002 administration groups are not inferior to Active control…
- Trial name
- NCT03419975
- Testing
- TJO-002, Latanoprost
- Where
- South Korea
- Volunteers
- 146 people
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Psoriasis
Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis
The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in…
- Trial name
- halobetasol (NCT00715975)
- Testing
- halobetasol, clobetasol
- Where
- Brazil
- Volunteers
- 140 people
- Sponsor
- Azidus Brasil
Solid Cancers
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.
- Trial name
- NCT00977067
- Testing
- GDC-0152
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
Idiopathic Pulmonary Fibrosis
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
- Trial name
- PRM151F-12GL (NCT01254409)
- Testing
- PRM-151
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche