A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

Roche

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease

Treatments: Drug: placebo; Drug: dalcetrapib (RO4607381)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400439

NC20716

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who have completed treatment on study NC19453.

Exclusion criteria

• any significant lymph node abnormalities at the end of study NC19453.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups, including a placebo group

dalcetrapib (RO4607381)

Experimental group

Treatment:

Drug: dalcetrapib (RO4607381)

placebo

Placebo Comparator group

Treatment:

Drug: placebo