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NCT01239004 · ClinicalTrials.gov registry record · Phase 4
Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy
A Phase 4 study of Dyslipidemia and Hyperglycemia, sponsored by Radiant Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
- 4
- Study locations
NCT01239004: Completed Phase 4 study of Dyslipidemia and Hyperglycemia, sponsored by Radiant Research.
NCT01239004 is a Phase 4 study of Dyslipidemia and Hyperglycemia that has completed, run by Radiant Research. The registered enrollment target is 140 participants, below the 360-participant average among 40 other Dyslipidemia trials with a reported enrollment target (61% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239004, a Phase 4 study of Dyslipidemia and Hyperglycemia, has completed, sponsored by Radiant Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
- 4
- Study locations
Study Summary
The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in dyslipidemic subjects with impaired fasting glucose.
Primary Outcome
The primary efficacy endpoint will be the mean percent change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in LDL-C. It will be measured as part of the fasting lipid panel at Visits 1, 2, 3, 7, and 8/ET (Weeks -6 to -2, -1, 1, 10 and 12/ET).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Colesevelam
Study Locations (4)
Illinois
- Radiant Research - Chicago
Kansas
- - Kansas City
Minnesota
- - Minneapolis
Missouri
- - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT01239004 record still lists
NCT01239004 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 360-participant average among 40 other Dyslipidemia trials with a reported enrollment target (61% lower).
The record links to 3 conditions, with Dyslipidemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01239004 reports a single indexed study location in Illinois, Kansas, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01239004 about?
NCT01239004 is a clinical study titled "Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy". The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in dyslipidemic subjects with impaired fasting glucose.
What is the current status of trial NCT01239004?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2010-11. Estimated completion is 2011-08.
What conditions does trial NCT01239004 study?
This clinical trial studies the following conditions: Dyslipidemia, Hyperglycemia, Hyperlipidemia.
What interventions are being tested in trial NCT01239004?
The interventions under investigation include: Placebo (DRUG), Colesevelam (DRUG).
Who is sponsoring clinical trial NCT01239004?
This trial is sponsored by Radiant Research, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01239004 being conducted?
This trial has 4 study locations across Illinois, Kansas, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dyslipidemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01239004's enrollment target sits among peer trials
140 17th of 40 higher than 24 of 40 other Dyslipidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dyslipidemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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