A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)
1 other identifier
interventional
300
4 countries
33
Brief Summary
This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2011
Shorter than P25 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
August 6, 2018
CompletedJuly 30, 2019
July 1, 2019
1 year
March 24, 2011
July 6, 2018
July 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
4 weeks
Secondary Outcomes (6)
Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971
4 weeks
Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment
20 weeks
Percent Change From Baseline in Blood Lipid Levels
20 weeks
Percent Change From Baseline in Lipoprotein Levels
20 weeks
Percent Change From Baseline in Apolipoprotein Levels
20 weeks
- +1 more secondary outcomes
Study Arms (2)
Dalcetrapib
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/=45 years of age
- Patients admitted to the hospital for acute coronary syndrome (ACS)
- Patients receiving guideline-based medical and dietary management of dyslipidemia
You may not qualify if:
- Symptomatic congestive heart failure (NYHA Class III or IV)
- Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
- Uncontrolled hypertension
- Uncontrolled diabetes
- Severe anemia
- Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Pensacola, Florida, 32501, United States
Unknown Facility
Pensacola, Florida, 32504, United States
Unknown Facility
Saginaw, Michigan, 48602, United States
Unknown Facility
Saint Cloud, Minnesota, 56303, United States
Unknown Facility
Syracuse, New York, 13210, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
Chrudim, 537 25, Czechia
Unknown Facility
České Budějovice, 370 87, Czechia
Unknown Facility
Hradec Králové, 500 05, Czechia
Unknown Facility
Jihlava, 586 01, Czechia
Unknown Facility
Jindřichův Hradec, 377 38, Czechia
Unknown Facility
Prague, 100 34, Czechia
Unknown Facility
Semily, 513 31, Czechia
Unknown Facility
Teplice, 415 01, Czechia
Unknown Facility
Zlín, 762 75, Czechia
Unknown Facility
Znojmo, 669 02, Czechia
Unknown Facility
Amsterdam, 1091 AC, Netherlands
Unknown Facility
Arnhem, 6815 AD, Netherlands
Unknown Facility
Beverwijk, 1942 LE, Netherlands
Unknown Facility
Breda, 4818 CK, Netherlands
Unknown Facility
Den Helder, 1782GZ, Netherlands
Unknown Facility
Eindhoven, 5623 EJ, Netherlands
Unknown Facility
Gouda, 2803 HH, Netherlands
Unknown Facility
Heerlen, 6419 PC, Netherlands
Unknown Facility
Nieuwegein, 3435 CM, Netherlands
Unknown Facility
Nijmegen, 6532 SZ, Netherlands
Unknown Facility
Rotterdam, 3045 PM, Netherlands
Unknown Facility
Sneek, 8601 ZK, Netherlands
Unknown Facility
Edinburgh, EH16 4SA, United Kingdom
Unknown Facility
Glasgow, G31 2ER, United Kingdom
Unknown Facility
London, EC1M 6BQ, United Kingdom
Unknown Facility
Stoke-on-Trent, ST4 6QG, United Kingdom
Unknown Facility
Swansea, SA6 6NL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Black
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 25, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 30, 2019
Results First Posted
August 6, 2018
Record last verified: 2019-07