Trial · NCT00358826
Study Effect of VIA-2291 on Vascular Inflammation
NCT00358826, Phase 2, Completed, Tallikut Pharmaceuticals, Inc.; results first posted 2012-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Effect of VIA-2291 on Vascular Inflammation. Trials, record NCT00358826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00358826
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Effect of VIA-2291 on Vascular Inflammation
- NCT number
- NCT00358826
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 191 participants, actual
- Lead sponsor
- Tallikut Pharmaceuticals, Inc.
- Conditions
- Coronary Artery Disease
- Interventions
- VIA-2291, Placebo
- First posted
- 2006-08-01
- Last updated
- 2012-07-23
- Results first posted
- 2012-07-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Leukotriene E4 (LTE4) | Baseline and 12 weeks | Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate |
| Secondary | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study | Baseline and 12 weeks | |
| Other | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy | Baseline and 24 weeks | |
| Other | Change From Baseline in Noncalcified Plaque Volume | Baseline and 24 weeks | |
| Other | Change From Baseline in Mean Plaque Density | Baseline and 24 weeks | Plaque density is expressed in Hounsfield Units (HU) |
| Other | Change From Baseline in Percent Stenosis | Baseline and 24 weeks |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | Baseline and 12 weeks | Core Study Evaluable Population | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Leukotriene E4 (LTE4) | Baseline and 12 weeks | Core Study Evaluable Population | pg/mg Cr | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study | Baseline and 12 weeks | Evaluable Population | mg/L | MEDIAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy | Baseline and 24 weeks | Evaluable Population of the MDCT substudy | mg/L | MEDIAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Noncalcified Plaque Volume | Baseline and 24 weeks | Evaluable Population | mm^3 | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean Plaque Density | Baseline and 24 weeks | Evaluable Population | HU | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Percent Stenosis | Baseline and 24 weeks | Evaluable Population | Percentage | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | VIA-2291 25 mg | -88126 | 95% Confidence Interval 29.95 | pg/mL | |
| Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | VIA-2291 50 mg | -95703 | 95% Confidence Interval 31.01 | pg/mL | |
| Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | VIA-2291 100 mg | -122668 | 95% Confidence Interval 7.01 | pg/mL | |
| Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | Placebo | -20843 | 95% Confidence Interval 174.12 | pg/mL | |
| Change From Baseline in Leukotriene E4 (LTE4) | VIA-2291 25 mg | -26.8 | 95% Confidence Interval -39.3 to -14.4 | pg/mg Cr | |
| Change From Baseline in Leukotriene E4 (LTE4) | VIA-2291 50 mg | -38.6 | 95% Confidence Interval -51.7 to -25.5 | pg/mg Cr | |
| Change From Baseline in Leukotriene E4 (LTE4) | VIA-2291 100 mg | -56.5 | 95% Confidence Interval -70.2 to -42.9 | pg/mg Cr | |
| Change From Baseline in Leukotriene E4 (LTE4) | Placebo | 8.4 | 95% Confidence Interval -3.8 to 20.6 | pg/mg Cr | |
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study | VIA-2291 25 mg | -0.2 | Inter-Quartile Range -1.1 to 0.4 | mg/L | |
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study | VIA-2291 50 mg | -0.1 | Inter-Quartile Range -1.9 to 0.1 | mg/L |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study | STARTED | VIA-2291 25 mg | 49 | |
| Core Study | STARTED | VIA-2291 50 mg | 46 | |
| Core Study | STARTED | VIA-2291 100 mg | 44 | |
| Core Study | STARTED | Placebo | 52 | |
| Core Study | STARTED | VIA-2291 25 mg MDCT Substudy | 0 | |
| Core Study | STARTED | VIA-2291 50 mg MDCT Substudy | 0 | |
| Core Study | STARTED | VIA-2291 100 mg MDCT Substudy | 0 | |
| Core Study | STARTED | Placebo MDCT Substudy | 0 | |
| Core Study | COMPLETED | VIA-2291 25 mg | 46 | |
| Core Study | COMPLETED | VIA-2291 50 mg | 41 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events188
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 | Fatigue | General disorders | VIA-2291 25 mg | 4 | 49 | 4 |
| other | Fatigue | General disorders | VIA-2291 50 mg | 6 | 46 | 6 |
| other | Fatigue | General disorders | VIA-2291 100 mg | 7 | 44 | 7 |
| other | Fatigue | General disorders | Placebo | 5 | 52 | 5 |
| other | Non-cardiac Chest Pain | General disorders | VIA-2291 25 mg | 5 | 49 | 5 |
| other | Non-cardiac Chest Pain | General disorders | VIA-2291 50 mg | 3 | 46 | 3 |
| other | Non-cardiac Chest Pain | General disorders | VIA-2291 100 mg | 4 | 44 | 4 |
| other | Non-cardiac Chest Pain | General disorders | Placebo | 4 | 52 | 4 |
| other | Chest pain | General disorders | VIA-2291 25 mg | 3 | 49 | 3 |
| other | Chest pain | General disorders | VIA-2291 50 mg | 2 | 46 | 2 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VIA-2291 25 mg | ||
| Total, all-cause mortality | VIA-2291 50 mg | ||
| Total, all-cause mortality | VIA-2291 100 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | VIA-2291 25 mg | 42 | 49 |
| Total, other adverse events | VIA-2291 50 mg | 43 | 46 |
| Total, other adverse events | VIA-2291 100 mg | 42 | 44 |
| Total, other adverse events | Placebo | 45 | 52 |
| Total, serious adverse events | VIA-2291 25 mg | 4 | 49 |
| Total, serious adverse events | VIA-2291 50 mg | 3 | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00358826
GET https://conductscience.org/api/trials/v1/NCT00358826/results?page=2