A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00755352
First received: September 16, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.


Condition Intervention Phase
Hypercholesterolemia
Drug: pravastatin tablets and Welchol tablets
Drug: pravastatin tablets and Welchol placebo tablets
Phase 4

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: Efficacy of WelChol as an Add-on to Pravastatin Therapy

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The absolute change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • The absolute change and % change of total cholesterol from baseline to endpoint [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • The absolute change and % change of triglycerides from baseline to endpoint [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • The absolute change and % change of HDL-C from baseline to endpoint [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • The absolute change and % change of c-reactive protein from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: November 2002
Study Completion Date: April 2005
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pravastatin tablets and Welchol tablets
Drug: pravastatin tablets and Welchol tablets
pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
Placebo Comparator: 2
pravastatin tablets and Welchol placebo tablets
Drug: pravastatin tablets and Welchol placebo tablets
pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female > or = to 18 years of age
  • On a stable dose of pravastatin
  • LDL-C > or = to 100 mg/dL and < or = 250 mg/dL
  • Triglycerides < or = to 300 mg/dL
  • Women are not pregnant or breast-feeding or planning to become pregnant
  • Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion Criteria:

  • BMI > 40 kg/m2
  • History of allergic or toxic reaction to colesevelam HCL
  • History of swallowing disorder
  • Any serious condition that would interfere with the conduct 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: NCT00755352

Locations
United States, California
Los Angeles, California, United States
United States, Colorado
Castle Rock, Colorado, United States
United States, Florida
Jacksonville, Florida, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, New York
Rochester, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Tennessee
Bartlett, Tennessee, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Senior Director of Metabolic Research, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00755352     History of Changes
Other Study ID Numbers: WEL-407
Study First Received: September 16, 2008
Last Updated: September 16, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Colesevelam
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 September 16, 2014