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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00697203
First received: June 11, 2008
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-admi nistered with pravastatin in patients with low or relatively low HDL-C levels. P atients 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 al so 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: Placebo
Drug: Pravastatin
Drug: dalceptrapib
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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage and absolute change from baseline in HDL-C level\n [ 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\n [ 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 Start Date: July 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pravastatin
40mg po daily for 12 weeks
Drug: dalceptrapib
300mg po daily for 12 weeks
Experimental: 2 Drug: Pravastatin
40mg po daily for 12 weeks
Drug: dalceptrapib
600mg po daily for 12 weeks
Experimental: 3 Drug: Pravastatin
40mg po daily for 12 weeks
Drug: dalceptrapib
900mg 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00697203     History of Changes
Other Study ID Numbers: NC18589
Study First Received: June 11, 2008
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014