Trial · NCT00409578

Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome

NCT00409578, Phase 2, Completed, Novartis; results first posted 2011-02-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome. Trials, record NCT00409578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00409578

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Trial

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

Title: Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
NCT number: NCT00409578
Status: Completed
Phases: Phase 2
Enrollment: 1,101 participants, actual
Lead sponsor: Novartis
Conditions: Post Acute Coronary Syndrome, Myocardial Ischemia
Interventions: Placebo, Aliskiren 300 mg, Valsartan 320 mg, Aliskiren/valsartan 300/320 mg
First posted: 2006-12-11
Last updated: 2011-04-19
Results first posted: 2011-02-02

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 N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8	Baseline to Week 8	Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
Secondary	Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8	Baseline to Week 8	Blood samples for the measurement of BNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
Secondary	Percentage of Patients With a Cardiac Event	Baseline to Week 8	A cardiac event was defined as at least one of the following events: Cardiovascular death, recurrent myocardial infarction (MI), or hospitalization for congestive heart failure (CHF), all to be confirmed by adjudication.
Secondary	Percentage of Patients With a Composite Clinical-biochemical Event	Baseline to Week 8	A composite clinical-biochemical event was defined as at least one of the following events: cardiovascular death confirmed by adjudication, recurrent MI confirmed by adjudication, hospitalization for CHF confirmed by adjudication, and/or NT-proBNP =\> 200 pg/mL.

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 N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8	Baseline to Week 8	Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.	pg/mL	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8	Baseline to Week 8	Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.	pg/mL	GEOMETRIC_MEAN
SECONDARY	Percentage of Patients With a Cardiac Event	Baseline to Week 8	Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.	Percentage of patients	NUMBER
SECONDARY	Percentage of Patients With a Composite Clinical-biochemical Event	Baseline to Week 8	Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.	Percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8	Placebo	0.582	95% Confidence Interval 0.502 to 0.676	pg/mL
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8	Aliskiren 300 mg	0.563	95% Confidence Interval 0.483 to 0.656	pg/mL
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8	Valsartan 320 mg	0.614	95% Confidence Interval 0.526 to 0.716	pg/mL
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8	Aliskiren/Valsartan 300/320 mg	0.635	95% Confidence Interval 0.548 to 0.737	pg/mL
Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8	Placebo	0.642	95% Confidence Interval 0.535 to 0.770	pg/mL
Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8	Aliskiren 300 mg	0.597	95% Confidence Interval 0.495 to 0.720	pg/mL
Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8	Valsartan 320 mg	0.670	95% Confidence Interval 0.554 to 0.810	pg/mL
Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8	Aliskiren/Valsartan 300/320 mg	0.682	95% Confidence Interval 0.568 to 0.818	pg/mL
Percentage of Patients With a Cardiac Event	Placebo	2.9		Percentage of patients
Percentage of Patients With a Cardiac Event	Aliskiren 300 mg	4.9		Percentage of patients

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	280
Overall Study	STARTED	Aliskiren 300 mg	271
Overall Study	STARTED	Valsartan 320 mg	269
Overall Study	STARTED	Aliskiren/Valsartan 300/320 mg	281
Overall Study	COMPLETED	Placebo	228
Overall Study	COMPLETED	Aliskiren 300 mg	201
Overall Study	COMPLETED	Valsartan 320 mg	215
Overall Study	COMPLETED	Aliskiren/Valsartan 300/320 mg	214
Overall Study	NOT COMPLETED	Placebo	52
Overall Study	NOT COMPLETED	Aliskiren 300 mg	70

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events360

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	Angina pectoris	Cardiac disorders	Placebo	13	278
other	Angina pectoris	Cardiac disorders	Aliskiren 300 mg	9	264
other	Angina pectoris	Cardiac disorders	Valsartan 320 mg	14	268
other	Angina pectoris	Cardiac disorders	Aliskiren/Valsartan 300/320 mg	8	279
other	Hyperkalaemia	Metabolism and nutrition disorders	Placebo	17	278
other	Hyperkalaemia	Metabolism and nutrition disorders	Aliskiren 300 mg	16	264
other	Hyperkalaemia	Metabolism and nutrition disorders	Valsartan 320 mg	13	268
other	Hyperkalaemia	Metabolism and nutrition disorders	Aliskiren/Valsartan 300/320 mg	13	279
other	Dizziness	Nervous system disorders	Placebo	15	278
other	Dizziness	Nervous system disorders	Aliskiren 300 mg	23	264

1 to 10 of 360Source ClinicalTrials.gov

See all 360 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Aliskiren 300 mg
Total, all-cause mortality	Valsartan 320 mg
Total, all-cause mortality	Aliskiren/Valsartan 300/320 mg
Total, other adverse events	Placebo	64	278
Total, other adverse events	Aliskiren 300 mg	61	264
Total, other adverse events	Valsartan 320 mg	51	268
Total, other adverse events	Aliskiren/Valsartan 300/320 mg	57	279
Total, serious adverse events	Placebo	26	278
Total, serious adverse events	Aliskiren 300 mg	39	264

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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/NCT00409578

GET https://conductscience.org/api/trials/v1/NCT00409578/events?page=2

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