Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00389896
First received: October 18, 2006
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.


Condition Intervention Phase
HDL Cholesterol
Drug: MK0733 / Duration of Treatment: 18 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • HDL-C raising effects after 6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Effect on other lipids and lipoproteins at 6 weeks [ Time Frame: 6 weeks ]

Estimated Enrollment: 150
Study Start Date: August 2001
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Patient has stable Type 2 diabetes mellitus at Visit 1.
  • Patient meets screening criteria based on Visit 1 lab tests

Exclusion Criteria:

  • Patient is pregnant, breastfeeding, or at risk of becoming pregnant
  • Patient has heart disease, uncontrolled high blood pressure, or other significant disease
  • Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study
  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: NCT00389896

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00389896     History of Changes
Other Study ID Numbers: 2006_536
Study First Received: October 18, 2006
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Simvastatin
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 24, 2014