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

Phase 4CompletedNCT00185107

Daiichi Sankyo45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Colesevelam HydrochlorideDRUG

EzetimibeDRUG

SimvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (7)

Scripps Clinic

San Diego, California, United States

Renstar Medical Research

Ocala, Florida, United States

Radiant Research

Overland Park, Kansas, United States

L-MARC Research Center

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

The percent change in LDL-C from the start of the study

Secondary Outcomes

- 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

Data from ClinicalTrials.gov

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