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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185107
First received: September 9, 2005
Last updated: September 10, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
Drug: Colesevelam Hydrochloride
Drug: Ezetimibe
Drug: Simvastatin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The percent change in LDL-C from the start of the study

Secondary Outcome 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

Estimated Enrollment: 45
Study Start Date: March 2005
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185107

Locations
United States, California
Scripps Clinic
San Diego, California, United States, 92128
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Kansas
Radiant Research
Overland Park, Kansas, United States, 66215
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
United States, North Carolina
Medical Office
Statesville, North Carolina, United States, 28677
United States, Ohio
Linder Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00185107     History of Changes
Other Study ID Numbers: WEL-408
Study First Received: September 9, 2005
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Safety
Efficacy
WelChol®
Zocor®
Zetia®

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Colesevelam
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014