Advertisement

Topics

A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

2014-07-23 21:22:17 | BioPortfolio

Summary

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

Study Design

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

Conditions

Dyslipidemia

Intervention

RO4607381, RO4607381, RO4607381, Placebo, Pravastatin

Location

Mobile
Alabama
United States
36608

Status

Completed

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:22:17-0400

Clinical Trials [261 Associated Clinical Trials listed on BioPortfolio]

A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patie...

A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors....

A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

This study will assess the safety, tolerability and efficacy of RO4607381 in pat ients with coronary heart disease (CHD) or CHD risk equivalents. Patients will b e randomized to receive ei...

A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a CHD risk equivalent who have completed study NC19453. Patients elig...

A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and...

PubMed Articles [1103 Associated PubMed Articles listed on BioPortfolio]

Effect of resveratrol supplementation on lipid profile in subjects with dyslipidemia: A randomized double-blind, placebo-controlled trial.

The aim of this study was to explore the effect of resveratrol supplementation on lipid profile in individuals with dyslipidemia.

Towards more specific treatment for diabetic dyslipidemia.

Treatment of diabetic dyslipidemia is necessary because of its impact on cardiovascular disease, which is the leading cause of death in patients with diabetes. In the past, standard treatment of diabe...

Pravastatin alleviates interleukin 1β-induced cartilage degradation by restoring impaired autophagy associated with MAPK pathway inhibition.

Osteoarthritis (OA) is a chronic degenerative joint disease characterized by cartilage degradation driven by proinflammatory cytokines; meanwhile, statins display anti-inflammatory effects. Here we as...

Dyslipidemia and hypertension - what to worry about more?

Dyslipidemia is present in every other patient with arterial hypertension. With increasing blood pressure and cholesterol levels, the risk of cardiovascular events increases proportionally. Treatment ...

Impact on Dyslipidemia After Laparoscopic Sleeve Gastrectomy.

Improvement of dyslipidemia is an important benefit of bariatric surgery. The benefits of laparoscopic sleeve gastrectomy (LSG) among dyslipidemia are still a matter of debate.

Medical and Biotech [MESH] Definitions

An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.

A cluster of metabolic risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome X include excess ABDOMINAL FAT; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state. (from AHA/NHLBI/ADA Conference Proceedings, Circulation 2004; 109:551-556)

More From BioPortfolio on "A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial