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NCT01059682 · ClinicalTrials.gov registry record · Phase 3
A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 936
- Enrollment target
NCT01059682 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 936 participants.
The verdict
NCT01059682, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 936 participants
- Enrollment target
Study Summary
This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.
Interventions
- DRUG Placebo
- DRUG Dalcetrapib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 936 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059682
The ClinicalTrials.gov registry entry for NCT01059682 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 936 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01059682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01059682 about?
NCT01059682 is a clinical study titled "A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease". This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disea...
What is the current status of trial NCT01059682?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 936 participants. The study started on 2010-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01059682?
The interventions under investigation include: Placebo (DRUG), Dalcetrapib (DRUG).
Who is sponsoring clinical trial NCT01059682?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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