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

NCT00400439

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Coronary Heart Disease

Interventions: dalcetrapib (RO4607381), placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* patients who have completed treatment on study NC19453.

Exclusion Criteria:

* any significant lymph node abnormalities at the end of study NC19453.
Locations (9)
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Louisville, Kentucky, United States
  • Bethesda, Maryland, United States
  • Minneapolis, Minnesota, United States
  • Statesville, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Salt Lake City, Utah, United States