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NCT00697203 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
292
Enrollment target

NCT00697203 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 292 participants.

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The verdict

NCT00697203, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
292 participants
Enrollment target

Study Summary

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

Interventions

  • DRUG Placebo
  • DRUG Dalcetrapib
  • DRUG Pravastatin

Trial Details

FieldValue
Enrollment Target 292 participants
Start Date 2005-07
Est. Completion 2006-05
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT00697203

The ClinicalTrials.gov registry entry for NCT00697203 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 292 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 3 interventions - of which Placebo is the first listed.

NCT00697203 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00697203 about?

NCT00697203 is a clinical study titled "A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)". This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks....

What is the current status of trial NCT00697203?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 292 participants. The study started on 2005-07. Estimated completion is 2006-05.

What interventions are being tested in trial NCT00697203?

The interventions under investigation include: Placebo (DRUG), Dalcetrapib (DRUG), Pravastatin (DRUG).

Who is sponsoring clinical trial NCT00697203?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.