NC25608 Dalcetrapib and CV events in risk patients for CHD or CVD.
Research type
Research Study
Full title
A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients with Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD). NC25608 (Dal Outcomes 2)
IRAS ID
93725
Contact name
Adrian Brady
Sponsor organisation
F. Hoffman-La Roche
Eudract number
2011-001891-21
Clinicaltrials.gov Identifier
Research summary
This is a research study of an experimental new drug named dalcetrapib. Eligible patients will be those who have stable coronary heart disease (CHD), patients with risk of developing CHD or patients at elevated risk for developing cardiovascular disease (CVD). The purpose of the study is to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in adult patients with stable coronary heart disease (CHD), patients with risk of developing CHD or patients at elevated risk for developing cardiovascular disease (CVD). During randomisation, eligible patients will be randomly assigned by chance to receive treatment with either 600mg of dalcetrapib or placebo for up to approximately 4-5 years. Neither the patient nor the study doctor will know which treatment the patient is receiving. Patients will receive the study treatment in addition to the current standard of care for patients with these medical conditions. This trial will last until approximately 1,250 patients are anticipated to have experienced a primary endpoint event. This is expected to occur up to approximately 4-5 years after the first patient is randomised. Patients will visit the clinic 1 and 6 months after randomisation and every 6 months thereafter until completion of the study. Patients will be contacted by phone 3 months after randomisation. Patients prematurely and permanently discontinuing study treatment will be followed up by adhering to the visit schedule or will be contacted by phone every 6 months until the end of the study to assess occurrence of CV events and vital status. A phone safety follow-up visit will be performed 4 weeks after the end of treatment visit.
REC name
West of Scotland REC 1
REC reference
12/WS/0006
Date of REC Opinion
3 Apr 2012
REC opinion
Further Information Favourable Opinion