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A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANACETRAPIB WHEN ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHD RISK-EQUIVALENT DISEASE: EVALUATION OF ANACETRAPIB LEVELS IN PLASMA AND ADIPOSE TISSUE IN PATIENTS WHO WERE PREVIOUSLY TREATED WITH ANACETRAPIB IN THE PROTOCOL 019, DEFINE STUDY

A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANACETRAPIB WHEN ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHD RISK-EQUIVALENT DISEASE: EVALUATION OF ANACETRAPIB LEVELS IN PLASMA AND ADIPOSE TISSUE IN PATIENTS WHO WERE PREVIOUSLY TREATED WITH ANACETRAPIB IN THE PROTOCOL 019, DEFINE STUDY

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-004-14
Enrollment
6
Registered
2014-03-28
Start date
2014-05-14
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients participating in the DEFINE, PN 019-06 study. 2. Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient has any disorder, condition, requires any medication, or is at higher risk of infection, for which the adipose biopsy procedure puts the patient at risk. 2. The patient has an allergy or sensitivity to lidocaine. 3. The patient has recently had major surgery (within last 6 months). 4. The patient has any abdominal disorders, wounds, or scars which could impact the quality of the adipose biopsy specimen. 5. Patient is taking anti-coagulants (e.g. warfarin, and factor Xa inhibitors, dabigatran). Note: Aspirin and P2Y12 inhibitors (e.g. clopidogrel) are allowed. 6. Patient’s BMI is <20 kg/m2. 7. Patient is participating, or has participated in any other anacetrapib trial, except the PN 019 study.

Countries

Germany, Peru, Spain, Sweden, United States

Contacts

Public ContactNelva Garcia

MERCK SHARP & DOHME PERU S.R.L

nelva.garcia.coral@merck.com411-5187

Outcome results

None listed

Source: REPEC (via WHO ICTRP)