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

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ClinicalTrials.gov Identifier: NCT00755352
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: pravastatin tablets and Welchol tablets Drug: pravastatin tablets and Welchol placebo tablets Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of WelChol as an Add-on to Pravastatin Therapy
Study Start Date : November 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : April 2005


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. The absolute change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ]
  2. The absolute change and % change of total cholesterol from baseline to endpoint [ Time Frame: 6 Weeks ]
  3. The absolute change and % change of triglycerides from baseline to endpoint [ Time Frame: 6 Weeks ]
  4. The absolute change and % change of HDL-C from baseline to endpoint [ Time Frame: 6 Weeks ]
  5. The absolute change and % change of c-reactive protein from baseline to endpoint [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00755352     History of Changes
Other Study ID Numbers: WEL-407
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors