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OpenTrials
Completed

NCT Number: NCT00185107

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 cholesterol

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scripps Clinic, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colesevelam hydrochloride

Drug

ezetimibe

Drug

simvastatin

Drug

Primary outcomes

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

Secondary outcomes

  1. - The absolute change in LDL-C from baseline

  2. - The percent change in LDL-C from baseline

  3. - The absolute changes and percent changes in TG, non-HDL-

  4. C, HDL-C, total cholesterol and other lipid measures

  5. - The percentages of patients who achieve target levels of LDL-C at the end of the study

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Sep 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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