A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01323153
First received: March 24, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This double-blind, randomized, placebo-controlled, multi-center study will evalu ate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the AC S. 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.


Condition Intervention Phase
Coronary Heart Disease
Drug: dalcetrapib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 CV Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Similarity in percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment in studies WC25501 and NC20971 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Percent change of high-density lipoprotein C (HDL-C) treatment levels after 8, 12 and 20 weeks of treatment [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in blood lipid levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in Lipoprotein levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in Apolipoprotein levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
Oral doses of 600 mg once daily for 20 weeks
Placebo Comparator: 2 Drug: placebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323153

Locations
United States, Florida
Pensacola, Florida, United States, 32504
Pensacola, Florida, United States, 32501
United States, Michigan
Saginaw, Michigan, United States, 48602
United States, Minnesota
St. Cloud, Minnesota, United States, 56303
United States, New York
Syracuse, New York, United States, 13210
United States, South Dakota
Rapid City, South Dakota, United States, 57701
Czech Republic
Ceske Budejovice, Czech Republic, 370 87
Chrudim, Czech Republic, 537 25
Hradec Kralove, Czech Republic, 500 05
Jihlava, Czech Republic, 586 01
Jindrichuv Hradec, Czech Republic, 377 38
Praha, Czech Republic, 100 34
Semily, Czech Republic, 513 31
Teplice, Czech Republic, 415 01
Zlin, Czech Republic, 762 75
Znojmo, Czech Republic, 669 02
Netherlands
Amsterdam, Netherlands, 1091 AC
Arnhem, Netherlands, 6815 AD
Beverwijk, Netherlands, 1942 LE
Breda, Netherlands, 4818 CK
Den Helder, Netherlands, 1782GZ
Eindhoven, Netherlands, 5623 EJ
Gouda, Netherlands, 2803 HH
Heerlen, Netherlands, 6419 PC
Nieuwegein, Netherlands, 3435 CM
Nijmegen, Netherlands, 6532 SZ
Rotterdam, Netherlands, 3045 PM
Sneek, Netherlands, 8601 ZK
United Kingdom
Edinburgh, United Kingdom, EH16 4SA
Glasgow, United Kingdom, G31 2ER
London, United Kingdom, EC1M 6BQ
Stoke-on-Trent, United Kingdom, ST4 6QG
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01323153     History of Changes
Other Study ID Numbers: WC25501
Study First Received: March 24, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014