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Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00754039
First received: September 15, 2008
Last updated: September 16, 2008
Last verified: September 2008

September 15, 2008
September 16, 2008
February 2003
September 2003   (final data collection date for primary outcome measure)
% change in LDL-C from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00754039 on ClinicalTrials.gov Archive Site
  • The absolute change in LDL-C from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • The absolute change and % change in LDL-C from week -8 (untreated) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • The percentage of patients who achieved target LDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Hyperlipidemia, Familial Combined
  • Drug: colesevelam HCl tablets and fenofibrate tablets
    Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
  • Drug: fenofibrate tablets and Welchol placebo tablets
    fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
  • Drug: fenofibrate tablets and Welchol placebo tablets
    fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
  • Experimental: 1
    Welchol + TriCor
    Intervention: Drug: colesevelam HCl tablets and fenofibrate tablets
  • Placebo Comparator: 2
    Welchol + placebo
    Interventions:
    • Drug: fenofibrate tablets and Welchol placebo tablets
    • Drug: fenofibrate tablets and Welchol placebo tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
March 2004
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 30-70 years of age
  • History of mixed hyperlipidemia
  • Prescribed a Step 1 diet at least 30 days prior to screening
  • Women were not pregnant, breast-feeding, or plan to become pregnant during the study
  • Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
  • Serum LDL-C >/= 115 mg/dL; Serum TG >/= 150 & < 750 mg/dL

Exclusion Criteria:

  • BMI >40
  • HbA1C > 10%
  • Type 1 diabetes
  • Intolerance to fibrates
  • History of intolerance to colesevelam HCl
  • History of swallowing disorders or intestinal motility disorders
  • Any other disorder that might interfere with the conduct of the study
  • History of drug or alcohol abuse
  • Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00754039
WEL-403
No
Senior Director, Metabolic Medical Research, Daiichi Sankyo
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP