Trial · NCT00655538
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
NCT00655538, Phase 2, Completed, Hoffmann-La Roche; results first posted 2020-01-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients. Trials, record NCT00655538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00655538
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
- NCT number
- NCT00655538
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 476 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Coronary Heart Disease
- Interventions
- Placebo, dalcetrapib
- First posted
- 2008-04-10
- Last updated
- 2020-01-02
- Results first posted
- 2020-01-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in % Flow Mediated Dilatation (FMD) | Baseline and 12 weeks | |
| Primary | Change From Baseline in Mean BP, Measured by BP Monitoring | Baseline and 4 weeks | |
| Secondary | Change From Baseline in % FMD | baseline and 36 weeks | |
| Secondary | Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Baseline to 36 weeks | |
| Secondary | CETP Activity | Up to 36 weeks | |
| Secondary | Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9 | Baseline and 36 weeks | |
| Secondary | Change From Baseline in Mean BP, Measured by BP Monitoring | Up to 36 weeks | |
| Secondary | Percent Change CETP Mass | baseline to 36 weeks |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in % Flow Mediated Dilatation (FMD) | Baseline and 12 weeks | 10 subjects dropped before week 12 | %FMD | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Mean BP, Measured by BP Monitoring | Baseline and 4 weeks | not all participants were tested | mmHg | MEAN |
| SECONDARY | Change From Baseline in % FMD | baseline and 36 weeks | not all participants were tested | %FMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Baseline to 36 weeks | not all participants were tested | Percent change in mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | CETP Activity | Up to 36 weeks | not all participants were tested | Percent change pMOL/uL/hr | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9 | Baseline and 36 weeks | not all participants were tested | Percent change in ng/mL | MEAN |
| SECONDARY | Change From Baseline in Mean BP, Measured by BP Monitoring | Up to 36 weeks | not all participants were tested | mmHg | MEAN |
| SECONDARY | Percent Change CETP Mass | baseline to 36 weeks | not all participants were tested | Percent change in ug/mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in % Flow Mediated Dilatation (FMD) | Dalcetrapib | 0.09 | Standard Error 0.13 | %FMD | |
| Change From Baseline in % Flow Mediated Dilatation (FMD) | Placebo | 0.32 | Standard Error 0.13 | %FMD | |
| Change From Baseline in Mean BP, Measured by BP Monitoring | Dalcetrapib | 0.91 | Standard Error 0.57 | mmHg | |
| Change From Baseline in Mean BP, Measured by BP Monitoring | Placebo | 0.31 | Standard Error 0.57 | mmHg | |
| Change From Baseline in % FMD | Dalcetrapib | 10.50 | Standard Deviation 6.27 | %FMD | |
| Change From Baseline in % FMD | Placebo | 20.13 | Standard Deviation 5.95 | %FMD | |
| Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Dalcetrapib | HDL-C | 30.70 | Standard Error 1.45 | Percent change in mg/dL |
| Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Placebo | HDL-C | -0.14 | Standard Error 1.42 | Percent change in mg/dL |
| Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Dalcetrapib | LDL-C | 4.43 | Standard Error 2.22 | Percent change in mg/dL |
| Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Placebo | LDL-C | 8.72 | Standard Error 2.18 | Percent change in mg/dL |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalcetrapib | 238 | |
| Overall Study | STARTED | Placebo | 238 | |
| Overall Study | COMPLETED | Dalcetrapib | 214 | |
| Overall Study | COMPLETED | Placebo | 211 | |
| Overall Study | NOT COMPLETED | Dalcetrapib | 24 | |
| Overall Study | NOT COMPLETED | Placebo | 27 |
Source ClinicalTrials.gov
Adverse events66
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 | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Dalcetrapib | 38 | 236 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 42 | 236 | |
| other | Influenza | Infections and infestations | Dalcetrapib | 9 | 236 | |
| other | Influenza | Infections and infestations | Placebo | 15 | 236 | |
| other | Diarrhea | Gastrointestinal disorders | Dalcetrapib | 27 | 236 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 26 | 236 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Dalcetrapib | 8 | 236 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo | 16 | 236 | |
| other | Headache | Nervous system disorders | Dalcetrapib | 10 | 236 | |
| other | Headache | Nervous system disorders | Placebo | 13 | 236 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalcetrapib | 0 | 236 |
| Total, all-cause mortality | Placebo | 1 | 236 |
| Total, other adverse events | Dalcetrapib | 92 | 236 |
| Total, other adverse events | Placebo | 112 | 236 |
| Total, serious adverse events | Dalcetrapib | 12 | 236 |
| Total, serious adverse events | Placebo | 14 | 236 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dalcetrapib vs Placebo: deaths from any cause | Trial comparisons |
| Dalcetrapib vs Placebo: serious adverse events | 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.
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/NCT00655538
GET https://conductscience.org/api/trials/v1/NCT00655538/results?page=2