Clinical Trials Logo
  1. Home
  2. Dyslipidemia
  3. NCT01972178

Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia

Dyslipidemia Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

Clinical Trial Summary

The objective of this study is

- To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameter from baseline after 12 weeks of treatment

- To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

Clinical Trial Description

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01972178
Study type Interventional
Source Pronova BioPharma
Contact
Status Terminated
Phase Phase 2
Start date November 2013
Completion date August 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT02837367 - Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People N/A
Active, not recruiting NCT02600338 - Meta-analyses of the Effect of Legumes on Blood Pressure N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01764295 - Clinical Study for Patients With Hypertension Associated With Dyslipidemia Phase 3
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Terminated NCT01414166 - Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108) Phase 3
Completed NCT01531062 - Effect of Nigella Sativa on Lipid Profiles in Elderly Phase 2
Recruiting NCT01670968 - HIV Reverse Cholesterol Transport Study
Completed NCT00977288 - A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029) Phase 2
Completed NCT00768274 - Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol Phase 1/Phase 2
Withdrawn NCT00664287 - Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082) Phase 3
Completed NCT01285544 - The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia Phase 4
Completed NCT01483235 - Reduced Cardiac Rehabilitation Program N/A
Completed NCT00300430 - Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. Phase 3
Terminated NCT00816829 - Effect of Fenofibrate on Sleep Apnea Syndrome Phase 2