Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Assess the efficacy of WelChol® plus Zetia® in treating patients with high...
Brief Summary
Official Title: “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia”
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Colesevelam Hydrochloride
- Drug: Ezetimibe
- Drug: Simvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- The percent change in LDL-C from the start of the study
Secondary Measures
- - The absolute change in LDL-C from baseline
- - The percent change in LDL-C from baseline
- - The absolute changes and percent changes in TG, non-HDL-
- C, HDL-C, total cholesterol and other lipid measures
- - The percentages of patients who achieve target levels of LDL-C at the end of the study
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 18-80 years of age, inclusive;
- A history of primary hypercholesterolemia
Exclusion Criteria:
- Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
- Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Daiichi Sankyo Inc. Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185107
Study ID Number: WEL-408
ClinicalTrials.gov Identifier: NCT00185107
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00185107
