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NCT00697203
A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels
Phase 2 trial testing Placebo in Dyslipidemia in 292 participants. Completed in 1 May 2006.
1 May 2006
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 292 |
| Start date | 1 July 2005 |
| Primary completion | 1 May 2006 |
| Estimated completion | 1 May 2006 |
| Sites | 33 locations across United States |
Drugs / interventions tested
- Placebo
- Pravastatin — full drug profile →
- Dalcetrapib — full drug profile →
- Dalcetrapib — full drug profile →
- Dalcetrapib — full drug profile →
Conditions studied
- Dyslipidemia — all drugs for Dyslipidemia →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 75, any sex, with Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Absolute Change From Baseline in HDL-C Level\n
Time frame: Week 12 -
Percent Change From Baseline in HDL-C Level\n
Time frame: 12 Weeks
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dalcetrapib: JTT 705; JTT-705; R 1658; R1658; RG1658; RO 4607381; RO4607381.
· 2010 · cited 1× · PMID 20509713 · DOI 10.2165/11537720-000000000-00000
Verify or expand the search:
- PubMed search for NCT00697203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hoffmann-La Roche trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00697203 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 13 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00697203.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing