Trial · NCT00529451

Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

NCT00529451, Phase 3, Completed, Novartis; results first posted 2011-03-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg. Trials, record NCT00529451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00529451

On this page

Trial

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

Title: Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
NCT number: NCT00529451
Status: Completed
Phases: Phase 3
Enrollment: 1,613 participants, actual
Lead sponsor: Novartis
Conditions: Hypertension
Interventions: Aliskiren, Ramipril
First posted: 2007-09-14
Last updated: 2011-03-25
Results first posted: 2011-03-25

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Primary	Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Primary	Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Secondary	Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Baseline and Week 8	To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.
Secondary	Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg	Week 8	To evaluate the percentage of patients controlled to a target blood pressure of \< 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.
Secondary	Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP	Week 8	To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP \< 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Baseline and Week 8	Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.	mm Hg	LEAST_SQUARES_MEAN
SECONDARY	Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg	Week 8	Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.	Percentage of participants	NUMBER
SECONDARY	Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP	Week 8	Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.	Percentage of participants	NUMBER
PRIMARY	Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.	mm Hg	LEAST_SQUARES_MEAN
PRIMARY	Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.	mm Hg	LEAST_SQUARES_MEAN
PRIMARY	Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.	mm Hg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Spread	Units
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Aliskiren 300 mg	msSBP	-14.39	Standard Error 0.66	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Aliskiren 150 mg	msSBP	-12.16	Standard Error 0.67	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Aliskiren 75 mg	msSBP	-12.24	Standard Error 0.66	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Ramipril 5 mg	msSBP	-11.46	Standard Error 0.66	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Aliskiren 300 mg	msDBP	-11.63	Standard Error 0.44	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Aliskiren 150 mg	msDBP	-10.04	Standard Error 0.44	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Aliskiren 75 mg	msDBP	-10.66	Standard Error 0.44	mm Hg
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	Ramipril 5 mg	msDBP	-9.19	Standard Error 0.44	mm Hg
Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg	Aliskiren 300 mg		52.29		Percentage of participants
Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg	Aliskiren 150 mg		48.11		Percentage of participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Aliskiren 300 mg	331
Overall Study	STARTED	Aliskiren 150 mg	323
Overall Study	STARTED	Aliskiren 75 mg	332
Overall Study	STARTED	Ramipril 5 mg	330
Overall Study	COMPLETED	Aliskiren 300 mg	294
Overall Study	COMPLETED	Aliskiren 150 mg	275
Overall Study	COMPLETED	Aliskiren 75 mg	292
Overall Study	COMPLETED	Ramipril 5 mg	299
Overall Study	NOT COMPLETED	Aliskiren 300 mg	37
Overall Study	NOT COMPLETED	Aliskiren 150 mg	48

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events32

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	Cough	Respiratory, thoracic and mediastinal disorders	Aliskiren 300 mg	4	331
other	Cough	Respiratory, thoracic and mediastinal disorders	Aliskiren 150 mg	3	323
other	Cough	Respiratory, thoracic and mediastinal disorders	Aliskiren 75 mg	2	332
other	Cough	Respiratory, thoracic and mediastinal disorders	Ramipril 5 mg	17	329
serious	Chest pain	General disorders	Aliskiren 300 mg	0	331
serious	Chest pain	General disorders	Aliskiren 150 mg	0	323
serious	Chest pain	General disorders	Aliskiren 75 mg	1	332
serious	Chest pain	General disorders	Ramipril 5 mg	0	329
serious	Head injury	Injury, poisoning and procedural complications	Aliskiren 300 mg	0	331
serious	Head injury	Injury, poisoning and procedural complications	Aliskiren 150 mg	1	323

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aliskiren 300 mg
Total, all-cause mortality	Aliskiren 150 mg
Total, all-cause mortality	Aliskiren 75 mg
Total, all-cause mortality	Ramipril 5 mg
Total, other adverse events	Aliskiren 300 mg	4	331
Total, other adverse events	Aliskiren 150 mg	3	323
Total, other adverse events	Aliskiren 75 mg	2	332
Total, other adverse events	Ramipril 5 mg	17	329
Total, serious adverse events	Aliskiren 300 mg	1	331
Total, serious adverse events	Aliskiren 150 mg	2	323

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33089502	DERIVED

Source PubMed

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/NCT00529451

GET https://conductscience.org/api/trials/v1/NCT00529451/results?page=2

API reference For AI assistants