Clinical trial NCT01323153: A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
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 Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Heart Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971
timeFrame: 4 weeks
measure: Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment
timeFrame: 20 weeks
measure: Percent Change From Baseline in Blood Lipid Levels
timeFrame: 20 weeks
measure: Percent Change From Baseline in Lipoprotein Levels
timeFrame: 20 weeks
measure: Percent Change From Baseline in Apolipoprotein Levels
timeFrame: 20 weeks
measure: Safety: Incidence of Adverse Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Pensacola
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Saginaw
country: United States
state: Michigan
city: Saint Cloud
country: United States
state: Minnesota
city: Syracuse
country: United States
state: New York
city: Rapid City
country: United States
state: South Dakota
city: Ceske Budejovice
country: Czechia
city: Chrudim
country: Czechia
city: Hradec Kralove
country: Czechia
city: Jihlava
country: Czechia
city: Jindrichuv Hradec
country: Czechia
city: Praha
country: Czechia
city: Semily
country: Czechia
city: Teplice
country: Czechia
city: Zlin
country: Czechia
city: Znojmo
country: Czechia
city: Amsterdam
country: Netherlands
city: Arnhem
country: Netherlands
city: Beverwijk
country: Netherlands
city: Breda
country: Netherlands
city: Den Helder
country: Netherlands
city: Eindhoven
country: Netherlands
city: Gouda
country: Netherlands
city: Heerlen
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Sneek
country: Netherlands
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Stoke-on-Trent
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: