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Number of records: 12
Title of the trial Diagnosis
High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS) Dyslipidemia
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double­Blind, 12-Week Study With a 40-Week, Active-Controlled, Double­Blind Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ?500 mg/dL and <2000 mg/dL and Normal Renal Function dyslipidemie
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease dyslipidemia
Fixed combination for lipid and blood pressure control. Randomized cross-over study. dyslipidemie a hypertenze
A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed combinations of Fenofibrate/Simvastatin 145/20 mg and Fenofibrate/Simvastatin 145/40 mg Tablets vs. Matching Monoterapies in Dyslipidemic Subjects at Hign Risk of cardiovascular disease in Dyslipidemic Subjects at Hign Risk of cardiovascular disease
A Double-Blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia Primary Hypercholesterolemia and Mixed Dyslipidemia
A worldwide, multicenter, double-blind, randomized, parallel, placebo-controlled 12-week study to evaluate the efficacy and safety of extended release (ER) Niacin/Laropiprant when added to ongoing lipid-modifying therapy in patients with primary hypercholestreolemia or mixed dyslipidemia Primary hypercholesterolemia or mixed dyslipidemia
A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of 1 g/10 mg Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablets in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia Primary Hypercholesterolemia or Mixed Dyslipidemia
A multi-center, randomised, double-blind, paralle-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 Primary hypercholesterolemia or mixed dyslipidemia
European trial about effect of Rimonabant on abdominal obese patients with dyslipidemia abdominal obese patients with dyslipidemia
A multi-center, double-blind, randomised, active-comparator, forced-titration study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 20 or 40 mg simvastatin with 40 mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 20 mg simvastatin alone mixed dyslipidemia at risk of cardiovascular disease
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. primary dyslipidemia
Pursuant to Section 99 par. 1 indent f) (2) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) as amended, the State Institute for Drug Control publishes information about clinical trials approved in the Czech Republic.
Database included clinical trials approved since the effect of the Act on Pharmaceuticals. Information about clinical trials from the year 2004 – 2007 are being supplemented continuously.
Database, according to Act, doesn´t include bioequivalence trials and clinical trials in phase I (i.e. first-in-man trials, the first stage of testing in human subjects).

Glossary of clinical trials terms:
Sponsor = An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
Study code / Protocol number = trial identifying number for sponsor
EudraCT number = EU trial identifying number
Subject = an individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control; patient or healthy volunteer.
MEK = Ethics Committee for Multicentric Clinical Trials
Double-blind study = A clinical trial design in which neither the participating individuals (subjects) nor the study staff knows which participants are receiving the investigational drug and which are receiving a placebo or another therapy.
Randomized trial = A study in which participants/subjects are randomly (i.e. by chance) assigned to one of two or more treatment arms of a clinical trial.
Multicentric trial = a clinical trial conducted according to a single protocol but at more than one site and therefore, carried out by more than one investigator.
Placebo = an inactive pill, liquid, or powder that has no treatment value.
Last database change: 1. October 2023 at 05:10
 

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