ePrivacy and GPDR Cookie Consent by TermsFeed Generator
Home / Clinical trials database

Searching

Enter one or more items to select relevant trials (e.g. indications…)






Age span:












Study state:



Number of records: 41
Title of the trial Diagnosis
Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16) heterozygous familial hypercholesterolemia and elevated LDL-cholesterol
Efficacy, safety, tolerability and quality of life of ongoing individually optimized? lipid-lowering therapy with or without inclisiran (KJX839) ? a randomized, placebo-controlled, double-blind multicenter phase IV study in participants with hypercholesterolemia hypercholesterolemia
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL-C ?70 mg/dL Who are Not Adequately Controlled by Their Lipid-Modifying Therapies hypercholesterolemia
An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous Familial Hypercholesterolemia
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia homozygous familial hypercholesterolemia
A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH). homozygous familial hypercholesterolemia (HoFH)
A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia Hypercholesterolemia
A Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Formulation of Zenon (Ezetimibe/Rosuvastatin Fixed Dose Combination) in Patients With Primary Hypercholesterolemia, Not Adequately Controlled on Statin Therapy Primary Hypercholesterolemia
A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HeFH) AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HeFH) AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy Persistent Hypercholesterolemia
An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase Heterozygous Familial Hypercholesterolemia
Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia
A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab CAD hypercholesterolemia
Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for Low Density Lipoprotein-Cholesterol (LDL-C) Reduction, as Add-On to Diet and Lipid-Lowering Therapy, in Pediatric Subjects 10 to 17 Yearsof Age With Heterozygous Familial Hypercholesterolemia (HeFH) Heterozygous Familial Hypercholesterolemia (HeFH)
A Multi-Country, Multicenter, Single-Arm, Open-Label Study to Document the Safety, Tolerability and Effect of Alirocumab on atherogenic lipoproteins in High Cardio-Vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-Modifying Therapies Hypercholesterolemia
A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia Familial Hypercholesterolemia
A two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evalu Homozygous Familial Hypercholesterolemia
Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia Hypercholesterolemia
A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects Hypercholesterolemic

1 2 3 › ››

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: 23. September 2023 at 05:10
 

2010 © SÚKL. Šrobárova 48, 100 41 Praha 10, +420 272 185 111, posta@sukl_cz.

Web portal supplier - QCM, s.r.o.