Trial · NCT00738049
Darusentan Effect on PET Uptake Heterogeneity
NCT00738049, Phase 2, Completed, K.Lance Gould; results first posted 2014-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Darusentan Effect on PET Uptake Heterogeneity. Trials, record NCT00738049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00738049
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Darusentan Effect on PET Uptake Heterogeneity
- NCT number
- NCT00738049
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- K.Lance Gould
- Conditions
- Coronary Artery Disease, Endothelial Dysfunction
- Interventions
- darusentan 100 mg
- First posted
- 2008-08-20
- Last updated
- 2014-08-15
- Results first posted
- 2014-08-15
- Limitations and caveats
- The trial was stopped after 20 enrollments as the manufacturer of darusentan halted further development of the drug after a negative phase 3 trial in resistant hypertension.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity | 0, 2, 4, and 6 weeks | Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from \>0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values. |
| Secondary | Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia | 0, 2, 4, and 6 weeks | |
| Secondary | Change During Darusentan Treatment in the Coronary Flow Reserve (CFR) | 0, 2, 4, and 6 weeks | CFR is calculated as the unitless ratio between hyperemic to resting flow |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity | 0, 2, 4, and 6 weeks | Statistical analysis is exploratory, therefore not easily planned. A paired t-test with 40 subjects will provide approximately 89% power to test the null hypothesis of no change in the homogeneity number versus a two-sided alternative at alpha= 5%,if the true mean change is 0.15,e.g.,a homogeneity index of 0.5 at baseline and 0.65 after darusentan. | No units | MEAN |
| SECONDARY | Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia | 0, 2, 4, and 6 weeks | cc/min/gm | MEAN | |
| SECONDARY | Change During Darusentan Treatment in the Coronary Flow Reserve (CFR) | 0, 2, 4, and 6 weeks | no units | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity | Baseline | 0.33 | Standard Deviation 0.04 | No units | |
| Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity | Darusentan 100mg | 0.39 | Standard Deviation 0.10 | No units | |
| Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia | Darusentan 100mg at Rest | 0.65 | Standard Deviation 0.13 | cc/min/gm | |
| Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia | Darusentan 100mg at Hyperemia | 1.97 | Standard Deviation 0.54 | cc/min/gm | |
| Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia | Baseline at Rest | 0.50 | Standard Deviation 0.10 | cc/min/gm | |
| Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia | Baseline at Hyperemia | 2.03 | Standard Deviation 0.56 | cc/min/gm | |
| Change During Darusentan Treatment in the Coronary Flow Reserve (CFR) | Baseline | 3.52 | Standard Deviation 0.80 | no units | |
| Change During Darusentan Treatment in the Coronary Flow Reserve (CFR) | Darusentan 100mg | 3.04 | Standard Deviation 0.61 | no units |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1st Intervention(14 Days) | STARTED | Darusentan Then Placebo, | 13 | |
| 1st Intervention(14 Days) | STARTED | Placebo, Then Darusentan 100mg | 7 | |
| 1st Intervention(14 Days) | COMPLETED | Darusentan Then Placebo, | 13 | |
| 1st Intervention(14 Days) | COMPLETED | Placebo, Then Darusentan 100mg | 7 | |
| 1st Intervention(14 Days) | NOT COMPLETED | Darusentan Then Placebo, | 0 | |
| 1st Intervention(14 Days) | NOT COMPLETED | Placebo, Then Darusentan 100mg | 0 | |
| 2nd Intervention(14 Days) | STARTED | Darusentan Then Placebo, | 13 | |
| 2nd Intervention(14 Days) | STARTED | Placebo, Then Darusentan 100mg | 7 | |
| 2nd Intervention(14 Days) | COMPLETED | Darusentan Then Placebo, | 13 | |
| 2nd Intervention(14 Days) | COMPLETED | Placebo, Then Darusentan 100mg | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, all-cause mortality | Group 2 | ||
| Total, other adverse events | Group 1 | 0 | 13 |
| Total, other adverse events | Group 2 | 0 | 7 |
| Total, serious adverse events | Group 1 | 0 | 13 |
| Total, serious adverse events | Group 2 | 0 | 7 |
Source ClinicalTrials.gov
Papers11
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 vs Group 2: 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.
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/NCT00738049
GET https://conductscience.org/api/trials/v1/NCT00738049/registered