Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185107
• Other study ID #: WEL-408
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: September 10, 2007
• Start date: March 2005
• Est. completion date: October 2005

Study information

• Verified date: September 2007
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Colesevelam Hydrochloride

• Ezetimibe

• Simvastatin

Locations

Country	Name	City	State
United States	Linder Clinical Trial Center	Cincinnati	Ohio
United States	Radiant Research	Edina	Minnesota
United States	L-MARC Research Center	Louisville	Kentucky
United States	Renstar Medical Research	Ocala	Florida
United States	Radiant Research	Overland Park	Kansas
United States	Scripps Clinic	San Diego	California
United States	Medical Office	Statesville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change in LDL-C from the start of the study
Secondary	- The absolute change in LDL-C from baseline
Secondary	- The percent change in LDL-C from baseline
Secondary	- The absolute changes and percent changes in TG, non-HDL-
Secondary	C, HDL-C, total cholesterol and other lipid measures
Secondary	- The percentages of patients who achieve target levels of LDL-C at the end of the study