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

NCT ID: NCT00185107

Last Updated: 2007-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-10-31

Brief Summary

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

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Colesevelam Hydrochloride

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Locations

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Scripps Clinic

San Diego, California, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Radiant Research

Overland Park, Kansas, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Radiant Research

Edina, Minnesota, United States

Site Status

Medical Office

Statesville, North Carolina, United States

Site Status

Linder Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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WEL-408

Identifier Type: -

Identifier Source: org_study_id