Trial · NCT01059682

A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease

NCT01059682, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2020-03-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease. Trials, record NCT01059682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059682

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
NCT number: NCT01059682
Status: Terminated
Phases: Phase 3
Enrollment: 936 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Cardiovascular Disease
Interventions: Dalcetrapib, Placebo
First posted: 2010-02-01
Last updated: 2020-03-24
Results first posted: 2020-03-24

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.	24 months
Primary	Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound	24 months
Secondary	Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography	24 months
Secondary	Blood Lipids, Lipoproteins	Throughout study, 24 months
Secondary	Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography	Throughout Study, 24 months

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.	24 months		Percent Change Atheroma Volume	MEAN
PRIMARY	Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound	24 months		mm/year	MEAN
SECONDARY	Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography	24 months		mm	MEAN
SECONDARY	Blood Lipids, Lipoproteins	Throughout study, 24 months	Data not collected
SECONDARY	Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography	Throughout Study, 24 months		Percent Diameter Stenosis	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.	Dalcetrapib	0.6	Standard Deviation 3.69	Percent Change Atheroma Volume
Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.	Placebo	0.5	Standard Deviation 2.01	Percent Change Atheroma Volume
Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound	Dalcetrapib	0.003	Standard Deviation 0.0588	mm/year
Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound	Placebo	0.003	Standard Deviation 0.0568	mm/year
Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography	Dalcetrapib	-0.1	Standard Deviation 0.18	mm
Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography	Placebo	0.0	Standard Deviation 0.10	mm
Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography	Dalcetrapib	9.2	Standard Deviation 20.65	Percent Diameter Stenosis
Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography	Placebo	4.3	Standard Deviation 14.36	Percent Diameter Stenosis

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dalcetrapib	474
Overall Study	STARTED	Placebo	462
Overall Study	COMPLETED	Dalcetrapib	464
Overall Study	COMPLETED	Placebo	444
Overall Study	NOT COMPLETED	Dalcetrapib	10
Overall Study	NOT COMPLETED	Placebo	18

Source ClinicalTrials.gov

Adverse events250

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	Dalcetrapib	41	474
other	Diarrhea	Gastrointestinal disorders	Placebo	27	462
other	Back Pain	Musculoskeletal and connective tissue disorders	Dalcetrapib	20	474
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	24	462
other	Nasopharyngitis	Infections and infestations	Dalcetrapib	27	474
other	Nasopharyngitis	Infections and infestations	Placebo	22	462
other	Chest Pain	General disorders	Dalcetrapib	48	474
other	Chest Pain	General disorders	Placebo	36	462
other	Headache	Nervous system disorders	Dalcetrapib	27	474
other	Headache	Nervous system disorders	Placebo	23	462

1 to 10 of 250Source ClinicalTrials.gov

See all 250 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dalcetrapib
Total, all-cause mortality	Placebo
Total, other adverse events	Dalcetrapib	255	474
Total, other adverse events	Placebo	199	462
Total, serious adverse events	Dalcetrapib	61	474
Total, serious adverse events	Placebo	63	462

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25583994	DERIVED	PubMed
27418594	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Dalcetrapib vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01059682

GET https://conductscience.org/api/trials/v1/NCT01059682/events?page=2

API reference For AI assistants