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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
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dalcetrapib Placebo
Hide Arm/Group Description dalcetrapib: Oral doses of 600 mg once daily for 20 weeks placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Period Title: Overall Study
Started 150 150
Completed 133 142
Not Completed 17 8
Arm/Group Title Dalcetrapib Placebo Total
Hide Arm/Group Description dalcetrapib: Oral doses of 600 mg once daily for 20 weeks placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks Total of all reporting groups
Overall Number of Baseline Participants 148 150 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 150 participants 298 participants
61  (9.77) 60.7  (10.09) 60.9  (9.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 150 participants 298 participants
Female
114
  77.0%
34
  22.7%
148
  49.7%
Male
34
  23.0%
116
  77.3%
150
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants 150 participants 298 participants
Netherlands 50 52 102
Czechia 74 75 149
United States 10 11 21
United Kingdom 14 12 26
1.Primary Outcome
Title Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
Hide Description [Not Specified]
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dalcetrapib Placebo
Hide Arm/Group Description:
dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Overall Number of Participants Analyzed 148 150
Least Squares Mean (Standard Error)
Unit of Measure: Percentage raise in HDL-C Levels
43.8  (2.5) 10.1  (2.5)
2.Secondary Outcome
Title Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment
Hide Description [Not Specified]
Time Frame 20 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percent Change From Baseline in Blood Lipid Levels
Hide Description [Not Specified]
Time Frame 20 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein Levels
Hide Description [Not Specified]
Time Frame 20 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein Levels
Hide Description [Not Specified]
Time Frame 20 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Safety: Incidence of Adverse Events
Hide Description [Not Specified]
Time Frame 24 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalcetrapib Placebo
Hide Arm/Group Description dalcetrapib: Oral doses of 600 mg once daily for 20 weeks placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
All-Cause Mortality
Dalcetrapib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dalcetrapib Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/148 (6.76%)      13/150 (8.67%)    
Cardiac disorders     
Angina Pectoris  1/148 (0.68%)  1 0/150 (0.00%)  0
Atrial Fibrillation  1/148 (0.68%)  1 0/150 (0.00%)  0
Supraventricular Tachicardia  1/148 (0.68%)  1 0/150 (0.00%)  0
Ventricular Tachicardia  1/148 (0.68%)  1 0/150 (0.00%)  0
Gastrointestinal disorders     
Gastric Haemorrhage  0/148 (0.00%)  0 1/150 (0.67%)  1
Gastrointestinal Haemorhage  0/148 (0.00%)  0 1/150 (0.67%)  1
Rectal Haemorrhage  1/148 (0.68%)  1 0/150 (0.00%)  0
General disorders     
Chest Pain  1/148 (0.68%)  1 0/150 (0.00%)  0
Non-Cardiac Chest Pain  1/148 (0.68%)  1 0/150 (0.00%)  0
Infections and infestations     
Liver Abscess  0/148 (0.00%)  0 1/150 (0.67%)  1
Mycobacterial Infection  1/148 (0.68%)  1 0/150 (0.00%)  0
Upper Respiratory Tract Infection Bacterial  1/148 (0.68%)  1 0/150 (0.00%)  0
Injury, poisoning and procedural complications     
Limb Injury  0/148 (0.00%)  0 1/150 (0.67%)  1
Road Traffic Accident  0/148 (0.00%)  0 1/150 (0.67%)  1
Metabolism and nutrition disorders     
Dehydration  1/148 (0.68%)  1 0/150 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1/148 (0.68%)  1 0/150 (0.00%)  0
Musculoskeletal Chest Pain  0/148 (0.00%)  0 1/150 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma  0/148 (0.00%)  0 1/150 (0.67%)  1
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)  1/148 (0.68%)  1 0/150 (0.00%)  0
Prostate Cancer  0/148 (0.00%)  0 1/150 (0.67%)  1
Rectosigmoid Cancer  0/148 (0.00%)  0 1/150 (0.67%)  1
Nervous system disorders     
Syncope  1/148 (0.68%)  1 0/150 (0.00%)  0
Psychiatric disorders     
Somatoform Disorder Gastrointestinal  0/148 (0.00%)  0 1/150 (0.67%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea Exertional  0/148 (0.00%)  0 1/150 (0.67%)  1
Epistaxis  0/148 (0.00%)  0 1/150 (0.67%)  1
Pulmonary Embolism  0/148 (0.00%)  0 1/150 (0.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dalcetrapib Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/148 (4.73%)      8/150 (5.33%)    
Gastrointestinal disorders     
Diarrhoea  7/148 (4.73%)  7 8/150 (5.33%)  8
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
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