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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00697203

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 II

MedlinePlus related topics: Cholesterol

Drug Information available for: Pravastatin Pravastatin sodium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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:	November 2005

Arms	Assigned Interventions
1: Experimental	Drug: RO4607381 300mg po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks
2: Experimental	Drug: RO4607381 600mg po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks
3: Experimental	Drug: RO4607381 900mg po daily for 12 weeks Drug: Pravastatin 40mg po daily for 12 weeks
4: Placebo Comparator	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, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NC18589
Study First Received:	June 11, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00697203
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pravastatin
Metabolic Diseases
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009