Trial · NCT00853827
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
NCT00853827, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-05-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients. Trials, record NCT00853827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
- NCT number
- NCT00853827
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 613 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Coronary Artery Disease (CAD), Coronary Atherosclerosis
- Interventions
- Placebo, Aliskiren
- First posted
- 2009-03-02
- Last updated
- 2014-06-03
- Results first posted
- 2014-05-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment | Baseline, 104 weeks | Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases |
| Secondary | Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS | Baseline, 104 weeks | Change from baseline in normalized total atheroma volume (TAV) (mm\^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases |
| Secondary | Patients That Demonstrated Evidence of Atheroma Regression | Baseline to endpoint (104 weeks) | Atheroma regression is defined as change from baseline to endpoint in PAV \<0 . |
| Secondary | Number of Patients With Adverse Events, Serious Adverse Events, and Death | 104 weeks | overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity. |
Source ClinicalTrials.gov
Outcomes4
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 Percent Atheroma Volume(PAV) After 104 Weeks of Treatment | Baseline, 104 weeks | Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis. | percentage of baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS | Baseline, 104 weeks | Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis. | mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Patients That Demonstrated Evidence of Atheroma Regression | Baseline to endpoint (104 weeks) | Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization | Participants | NUMBER |
| SECONDARY | Number of Patients With Adverse Events, Serious Adverse Events, and Death | 104 weeks | Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received | Number of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 Percent Atheroma Volume(PAV) After 104 Weeks of Treatment | Aliskiren | -0.33 | Standard Error 0.18 | percentage of baseline | |
| Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment | Placebo | 0.11 | Standard Error 0.18 | percentage of baseline | |
| Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS | Aliskiren | -4.11 | Standard Error 1.10 | mm^3 | |
| Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS | Placebo | -2.07 | Standard Error 1.09 | mm^3 | |
| Patients That Demonstrated Evidence of Atheroma Regression | Aliskiren | 128 | Participants | ||
| Patients That Demonstrated Evidence of Atheroma Regression | Placebo | 114 | Participants | ||
| Number of Patients With Adverse Events, Serious Adverse Events, and Death | Aliskiren | SAEs | 76 | Number of patients | |
| Number of Patients With Adverse Events, Serious Adverse Events, and Death | Placebo | SAEs | 97 | Number of patients | |
| Number of Patients With Adverse Events, Serious Adverse Events, and Death | Aliskiren | AE | 228 | Number of patients | |
| Number of Patients With Adverse Events, Serious Adverse Events, and Death | Placebo | AE | 227 | Number of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single Blind Period (1 Week) | STARTED | Aliskiren | 652 | |
| Single Blind Period (1 Week) | STARTED | Placebo | 0 | |
| Single Blind Period (1 Week) | COMPLETED | Aliskiren | 613 | |
| Single Blind Period (1 Week) | COMPLETED | Placebo | 0 | |
| Single Blind Period (1 Week) | NOT COMPLETED | Aliskiren | 39 | |
| Single Blind Period (1 Week) | NOT COMPLETED | Placebo | 0 | |
| Double Blind Period (103 Weeks) | STARTED | Aliskiren | 305 | |
| Double Blind Period (103 Weeks) | STARTED | Placebo | 308 | |
| Double Blind Period (103 Weeks) | Modified Full Analysis Set (mFAS) | Aliskiren | 225 | |
| Double Blind Period (103 Weeks) | Modified Full Analysis Set (mFAS) | Placebo | 233 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events408
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 | Angina pectoris | Cardiac disorders | Aliskiren 300 mg | 21 | 305 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 24 | 308 | |
| other | Palpitations | Cardiac disorders | Aliskiren 300 mg | 4 | 305 | |
| other | Palpitations | Cardiac disorders | Placebo | 8 | 308 | |
| other | Constipation | Gastrointestinal disorders | Aliskiren 300 mg | 8 | 305 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 10 | 308 | |
| other | Diarrhoea | Gastrointestinal disorders | Aliskiren 300 mg | 20 | 305 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 15 | 308 | |
| other | Dyspepsia | Gastrointestinal disorders | Aliskiren 300 mg | 5 | 305 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 8 | 308 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aliskiren 300 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Aliskiren 300 mg | 186 | 305 |
| Total, other adverse events | Placebo | 175 | 308 |
| Total, serious adverse events | Aliskiren 300 mg | 76 | 305 |
| Total, serious adverse events | Placebo | 97 | 308 |
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 |
|---|---|
| Aliskiren vs Placebo: Patients That Demonstrated Evidence of Atheroma Regression | Trial comparisons |
| Aliskiren 300 mg 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/NCT00853827
GET https://conductscience.org/api/trials/v1/NCT00853827/events?page=2