NCT00400439

A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

Completed Phase 2 Results posted Last updated 16 December 2019

What this trial tests

Phase 2 trial testing dalcetrapib (RO4607381) in Coronary Heart Disease in 77 participants. Completed in 1 January 2008.

Timeline

1 January 2007

Primary endpoint
1 January 2008

1 January 2008

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	77
Start date	1 January 2007
Primary completion	1 January 2008
Estimated completion	1 January 2008
Sites	9 locations across United States

Drugs / interventions tested

• dalcetrapib (RO4607381) — full drug profile →
• placebo

Conditions studied

• Coronary Heart Disease — all drugs for Coronary Heart Disease →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 75, any sex, with Coronary Heart Disease. 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.

• Percent Change From Baseline in HDL-C
  Time frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))

Sponsor's own description

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial.
   Stein EA, Roth EM, Rhyne JM, Burgess T, et al · · 2010 · cited 76× · PMID 20097702 · DOI 10.1093/eurheartj/ehp601