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Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

NCT01122108 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2010-10-07

Study results available
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Summary

The objective of this study is to compare the acceptability of Colesevelam HCl powder for oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated equivalent cholesterol lowering doses of each comparator drug.

Conditions

  • Healthy

Interventions

DRUG

Cholestyramine

Cholestyramine 12 grams, one time dose

DRUG

Colesevelam HCl

Colesevelam HCl, 4 grams, one time dose

Sponsors & Collaborators

  • Provident Clinical Research

    collaborator OTHER

  • Daiichi Sankyo

    collaborator INDUSTRY

  • Louisville Metabolic and Atherosclerosis Research Center

    lead OTHER

Principal Investigators

  • Harold E Bays, MD · L-MARC Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01122108 on ClinicalTrials.gov