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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: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT00697203 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 292 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Hoffmann-La Roche

909 total trials

What the finished NCT00697203 record still lists

NCT00697203 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00697203 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00697203's enrollment target sits among peer trials

292 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00697203, the US trial registry maintained by the National Library of Medicine. NCT00697203 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.