Trial Outcomes & Findings for A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease (NCT NCT01059682)
NCT ID: NCT01059682
Last Updated: 2020-03-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
936 participants
Primary outcome timeframe
24 months
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Dalcetrapib
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
Placebo: Placebo orally once daily
|
|---|---|---|
|
Overall Study
STARTED
|
474
|
462
|
|
Overall Study
COMPLETED
|
464
|
444
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Dalcetrapib
n=474 Participants
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=462 Participants
Placebo: Placebo orally once daily
|
Total
n=936 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 8.48 • n=99 Participants
|
60.4 years
STANDARD_DEVIATION 8.86 • n=107 Participants
|
60.5 years
STANDARD_DEVIATION 8.66 • n=206 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
347 Participants
n=99 Participants
|
354 Participants
n=107 Participants
|
701 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Dalcetrapib
n=474 Participants
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=462 Participants
Placebo: Placebo orally once daily
|
|---|---|---|
|
Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.
|
0.6 Percent Change Atheroma Volume
Standard Deviation 3.69
|
0.5 Percent Change Atheroma Volume
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Dalcetrapib
n=363 Participants
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=356 Participants
Placebo: Placebo orally once daily
|
|---|---|---|
|
Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound
|
0.003 mm/year
Standard Deviation 0.0588
|
0.003 mm/year
Standard Deviation 0.0568
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Dalcetrapib
n=474 Participants
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=462 Participants
Placebo: Placebo orally once daily
|
|---|---|---|
|
Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography
|
-0.1 mm
Standard Deviation 0.18
|
0.0 mm
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Throughout study, 24 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout Study, 24 monthsOutcome measures
| Measure |
Dalcetrapib
n=474 Participants
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=462 Participants
Placebo: Placebo orally once daily
|
|---|---|---|
|
Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography
|
9.2 Percent Diameter Stenosis
Standard Deviation 20.65
|
4.3 Percent Diameter Stenosis
Standard Deviation 14.36
|
Adverse Events
Dalcetrapib
Serious events: 61 serious events
Other events: 255 other events
Deaths: 0 deaths
Placebo
Serious events: 63 serious events
Other events: 199 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalcetrapib
n=474 participants at risk
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=462 participants at risk
Placebo: Placebo orally once daily
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
1.1%
5/474
|
0.65%
3/462
|
|
Cardiac disorders
Angina Unstable
|
0.42%
2/474
|
0.65%
3/462
|
|
Cardiac disorders
Atrial Fibrillation
|
0.63%
3/474
|
0.22%
1/462
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.21%
1/474
|
0.22%
1/462
|
|
Cardiac disorders
Prinzmetal Angina
|
0.00%
0/474
|
0.43%
2/462
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.21%
1/474
|
0.22%
1/462
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/474
|
0.22%
1/462
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/474
|
0.22%
1/462
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/474
|
0.22%
1/462
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/474
|
0.22%
1/462
|
|
Cardiac disorders
Sinus Bradycardia
|
0.21%
1/474
|
0.00%
0/462
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/474
|
0.22%
1/462
|
|
Cardiac disorders
Ventricular Tachicardia
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.21%
1/474
|
0.65%
3/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Lung Cancer
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancr Male
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melonoma
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm of Ampulla of Vater
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Metastatic
|
0.21%
1/474
|
0.00%
0/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Metastatic
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.00%
0/474
|
0.22%
1/462
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/474
|
0.22%
1/462
|
|
General disorders
Chest Pain
|
0.63%
3/474
|
1.5%
7/462
|
|
General disorders
Non-Cardiac Chest Pain
|
0.21%
1/474
|
0.43%
2/462
|
|
General disorders
Chest Discomfort
|
0.42%
2/474
|
0.00%
0/462
|
|
General disorders
Device Failure
|
0.00%
0/474
|
0.22%
1/462
|
|
General disorders
Medical Device Complication
|
0.00%
0/474
|
0.22%
1/462
|
|
General disorders
Pyrexia
|
0.00%
0/474
|
0.22%
1/462
|
|
Vascular disorders
Aortic Aneurism
|
0.21%
1/474
|
0.22%
1/462
|
|
Vascular disorders
Hypertension
|
0.21%
1/474
|
0.22%
1/462
|
|
Vascular disorders
Hypertensive Crisis
|
0.21%
1/474
|
0.22%
1/462
|
|
Vascular disorders
Intermittent Claudication
|
0.42%
2/474
|
0.00%
0/462
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.21%
1/474
|
0.00%
0/462
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/474
|
0.22%
1/462
|
|
Vascular disorders
Hematoma
|
0.00%
0/474
|
0.22%
1/462
|
|
Vascular disorders
Hypotension
|
0.21%
1/474
|
0.00%
0/462
|
|
Infections and infestations
Pneumonia
|
0.63%
3/474
|
0.43%
2/462
|
|
Infections and infestations
Clostridial Infection
|
0.21%
1/474
|
0.00%
0/462
|
|
Infections and infestations
Cystitis
|
0.00%
0/474
|
0.22%
1/462
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/474
|
0.22%
1/462
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/474
|
0.22%
1/462
|
|
Infections and infestations
Urosepsis
|
0.00%
0/474
|
0.22%
1/462
|
|
Infections and infestations
Wound Infection
|
0.00%
0/474
|
0.22%
1/462
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Coronary Disorder
|
0.21%
1/474
|
0.22%
1/462
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.21%
1/474
|
0.22%
1/462
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.21%
1/474
|
0.00%
0/462
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.21%
1/474
|
0.00%
0/462
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.21%
1/474
|
0.00%
0/462
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/474
|
0.22%
1/462
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/474
|
0.22%
1/462
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.21%
1/474
|
0.00%
0/462
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea Syndrome
|
0.21%
1/474
|
0.00%
0/462
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.21%
1/474
|
0.22%
1/462
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.21%
1/474
|
0.00%
0/462
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/474
|
0.00%
0/462
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/474
|
0.22%
1/462
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.21%
1/474
|
0.00%
0/462
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/474
|
0.22%
1/462
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/474
|
0.22%
1/462
|
|
Musculoskeletal and connective tissue disorders
Myositis Ossificans
|
0.00%
0/474
|
0.22%
1/462
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/474
|
0.22%
1/462
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/474
|
0.22%
1/462
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
1/474
|
0.65%
3/462
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/474
|
0.22%
1/462
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.21%
1/474
|
0.00%
0/462
|
|
Gastrointestinal disorders
Diarrhea Hemorrhagic
|
0.00%
0/474
|
0.22%
1/462
|
|
Gastrointestinal disorders
Dyspepsia
|
0.21%
1/474
|
0.00%
0/462
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.21%
1/474
|
0.00%
0/462
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.21%
1/474
|
0.00%
0/462
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.00%
0/474
|
0.22%
1/462
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.21%
1/474
|
0.00%
0/462
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/474
|
0.22%
1/462
|
|
Injury, poisoning and procedural complications
Limb Traumatic Amputaton
|
0.00%
0/474
|
0.22%
1/462
|
|
Injury, poisoning and procedural complications
Post Procedural Hemorrhage
|
0.21%
1/474
|
0.00%
0/462
|
|
Injury, poisoning and procedural complications
Post Procedural Pulmonary Embolism
|
0.21%
1/474
|
0.00%
0/462
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.21%
1/474
|
0.00%
0/462
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/474
|
0.43%
2/462
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/474
|
0.22%
1/462
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
1/474
|
0.00%
0/462
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/474
|
0.22%
1/462
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/474
|
0.22%
1/462
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.21%
1/474
|
0.00%
0/462
|
|
Nervous system disorders
Epilepsy
|
0.21%
1/474
|
0.00%
0/462
|
|
Nervous system disorders
Monoplegia
|
0.21%
1/474
|
0.00%
0/462
|
|
Nervous system disorders
Paraesthesia
|
0.21%
1/474
|
0.00%
0/462
|
|
Nervous system disorders
Polyneuropathy
|
0.21%
1/474
|
0.00%
0/462
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/474
|
0.22%
1/462
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/474
|
0.22%
1/462
|
|
Renal and urinary disorders
Hematuria
|
0.21%
1/474
|
0.00%
0/462
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/474
|
0.22%
1/462
|
|
Investigations
Arteriogram Coronary
|
0.21%
1/474
|
0.00%
0/462
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/474
|
0.22%
1/462
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/474
|
0.22%
1/462
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/474
|
0.22%
1/462
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/474
|
0.22%
1/462
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.21%
1/474
|
0.00%
0/462
|
|
Psychiatric disorders
Anxiety
|
0.42%
2/474
|
0.00%
0/462
|
|
Psychiatric disorders
Completed Suicide
|
0.21%
1/474
|
0.00%
0/462
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.21%
1/474
|
0.00%
0/462
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/474
|
0.22%
1/462
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/474
|
0.22%
1/462
|
|
Blood and lymphatic system disorders
Anaemia
|
0.21%
1/474
|
0.00%
0/462
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenia Purpura
|
0.00%
0/474
|
0.22%
1/462
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/474
|
0.22%
1/462
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.21%
1/474
|
0.00%
0/462
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.21%
1/474
|
0.00%
0/462
|
|
Surgical and medical procedures
Cataract Operation
|
0.21%
1/474
|
0.00%
0/462
|
|
Surgical and medical procedures
Gastrectomy
|
0.21%
1/474
|
0.00%
0/462
|
|
Endocrine disorders
Hyperthyroidism
|
0.21%
1/474
|
0.00%
0/462
|
Other adverse events
| Measure |
Dalcetrapib
n=474 participants at risk
Dalcetrapib: Dalcetrapib 600 mg orally once daily
|
Placebo
n=462 participants at risk
Placebo: Placebo orally once daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.6%
41/474
|
5.8%
27/462
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.2%
20/474
|
5.2%
24/462
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
27/474
|
4.8%
22/462
|
|
General disorders
Chest Pain
|
10.1%
48/474
|
7.8%
36/462
|
|
Nervous system disorders
Headache
|
5.7%
27/474
|
5.0%
23/462
|
|
Nervous system disorders
Dizziness
|
5.1%
24/474
|
4.8%
22/462
|
|
Vascular disorders
Hypertension
|
8.0%
38/474
|
4.1%
19/462
|
|
Cardiac disorders
Angina Pectoris
|
6.3%
30/474
|
5.6%
26/462
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place