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

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ClinicalTrials.gov Identifier: NCT01323153
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Coronary Heart Disease
Interventions: Drug: dalcetrapib
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dalcetrapib dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
Placebo placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Participant Flow:   Overall Study
    Dalcetrapib   Placebo
STARTED   150   150 
COMPLETED   133   142 
NOT COMPLETED   17   8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dalcetrapib dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
Placebo placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Total Total of all reporting groups

Baseline Measures
   Dalcetrapib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 148   150   298 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (9.77)   60.7  (10.09)   60.9  (9.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      114  77.0%      34  22.7%      148  49.7% 
Male      34  23.0%      116  77.3%      150  50.3% 
Region of Enrollment 
[Units: Participants]
     
Netherlands   50   52   102 
Czechia   74   75   149 
United States   10   11   21 
United Kingdom   14   12   26 


  Outcome Measures

1.  Primary:   Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment   [ Time Frame: 4 weeks ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment   [ Time Frame: 20 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Percent Change From Baseline in Blood Lipid Levels   [ Time Frame: 20 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Percent Change From Baseline in Lipoprotein Levels   [ Time Frame: 20 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Percent Change From Baseline in Apolipoprotein Levels   [ Time Frame: 20 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Safety: Incidence of Adverse Events   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ryan Black
Organization: DalCor Pharmaceuticals
e-mail: rblack@dalcorpharma.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01323153     History of Changes
Other Study ID Numbers: WC25501
First Submitted: March 24, 2011
First Posted: March 25, 2011
Results First Submitted: July 6, 2018
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018