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

Purpose

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.

Condition	Intervention	Phase
Dyslipidemia	Drug: RO4607381 Drug: Placebo Drug: Pravastatin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-Cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes Medicines

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage and absolute change from baseline in HDL-C level [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in: TC, TG, HDL-C, LDL-C, HDL-2, HDL-3, ApoAI, ApoAII, ApoB, ApoE, LpAI, oxidized LDL, and ratios of these lipid parameters [ Time Frame: 12 week period of double-blind treatment ] [ Designated as safety issue: No ]
Fasting glucose and insulin levels [ Time Frame: 12 week period of double-blind treatment ] [ Designated as safety issue: No ]
AEs, lab parameters, vital signs, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	292
Study Completion Date:	May 2006

Arms	Assigned Interventions
Experimental: 1	Drug: RO4607381 300mg po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks
Experimental: 2	Drug: RO4607381 600mg po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks
Experimental: 3	Drug: RO4607381 900mg po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks
Placebo Comparator: 4	Drug: Placebo po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients 18-75 years of age;
dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

Exclusion Criteria:

women who are pregnant, breastfeeding, or of child-bearing potential;
morbid obesity;
uncontrolled hypertension;
poorly controlled or insulin-treated diabetes;
high creatinine levels or history of statin-associated myopathy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697203

Show 33 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00697203 History of Changes
Other Study ID Numbers:	NC18589
Study First Received:	June 11, 2008
Last Updated:	May 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013