CompletedNCT00529451Updated Mar 25, 2011Results posted

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

A Phase 3 interventional study of Aliskiren and Ramipril in Hypertension, sponsored by Novartis. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-25.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,613
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,834

Keywords

Hypertension, Aliskiren, Ramipril

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 1,613 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Browse Novartis studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients must have msDBP ≥ 90 mmHg and \< 110 mmHg at the visit immediately prior to Visit 3
Patients must have msDBP >OR= 95 mmHg and \< 110 mmHg at Visit 3
Patients must have an absolute difference of \< or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion criteria

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,613 participants (actual)

Study arms

Experimental
Aliskiren 300 mg
Aliskiren 300 mg once daily
Drug: Aliskiren
Experimental
Aliskiren 150 mg
Aliskiren 150 mg once daily
Drug: Aliskiren
Experimental
Aliskiren 75 mg
Aliskiren 75 mg once daily
Drug: Aliskiren
Active comparator
Ramipril 5 mg
Ramipril 5 mg once daily
Drug: Ramipril

Interventions

DrugAliskiren
Aliskiren
DrugRamipril
comparator

What researchers measure

Primary outcomes

Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
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
Time frame: Baseline and Week 8
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
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
Time frame: Baseline and Week 8
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
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
Time frame: Baseline and Week 8

Secondary outcomes

Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
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.
Time frame: Baseline and Week 8
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
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.
Time frame: Week 8
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
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.
Time frame: Week 8

Results

Posted Mar 25, 2011

Participant flow

Participant flow — Overall Study
Milestone	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
Started	331	323	332	330
Completed	294	275	292	299
Not completed	37	48	40	31
Withdrew: Subject withdrew consent	16	21	13	12
Withdrew: Adverse event	9	16	14	8
Withdrew: Unsatisfactory therapeutic response	6	2	5	4
Withdrew: Lost to follow-up	4	7	4	4
Withdrew: Protocol deviation	1	1	4	1
Withdrew: Administrative problems	1	1	0	2

Outcome measures

SecondaryChange in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint

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.

Time frame:: Baseline and Week 8
Reported as:: Least squares mean · mm Hg

Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
mm Hg	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
msSBP	-14.39 ± 0.66	-12.16 ± 0.67	-12.24 ± 0.66	-11.46 ± 0.66
msDBP	-11.63 ± 0.44	-10.04 ± 0.44	-10.66 ± 0.44	-9.19 ± 0.44

SecondaryEvaluation 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

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.

Time frame:: Week 8
Reported as:: Number · 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
Percentage of participants	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
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	52.29	48.11	45.68	43.65

SecondaryEvaluation 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

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.

Time frame:: Week 8
Reported as:: Number · Percentage of participants

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
Percentage of participants	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
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	67.89	59.75	59.57	53.87

PrimaryNon-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)

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

Time frame:: Baseline and Week 8
Reported as:: Least squares mean · mm Hg

Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
mm Hg	Aliskiren 300 mg	Ramipril 5 mg
Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	-11.63 ± 0.44	-9.19 ± 0.44

Statistical analysis

Aliskiren 300 mg vs Ramipril 5 mg · Mean difference (final values): -2.44 · 95% CI -3.63 to -1.25

PrimaryNon-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)

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

Time frame:: Baseline and Week 8
Reported as:: Least squares mean · mm Hg

Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
mm Hg	Aliskiren 150 mg	Ramipril 5 mg
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	-10.04 ± 0.44	-9.19 ± 0.44

Statistical analysis

Aliskiren 150 mg vs Ramipril 5 mg · Mean difference (final values): -0.86 · 95% CI -2.06 to 0.34

PrimaryNon-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)

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

Time frame:: Baseline and Week 8
Reported as:: Least squares mean · mm Hg

Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
mm Hg	Aliskiren 75 mg	Ramipril 5 mg
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	-10.66 ± 0.44	-9.19 ± 0.44

Statistical analysis

Aliskiren 75 mg vs Ramipril 5 mg · Mean difference (final values): -1.48 · 95% CI -2.67 to -0.28

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aliskiren 300 mg	—	1/331 (0.3%)	4/331 (1.2%)
Aliskiren 150 mg	—	2/323 (0.6%)	3/323 (0.9%)
Aliskiren 75 mg	—	3/332 (0.9%)	2/332 (0.6%)
Ramipril 5 mg	—	1/329 (0.3%)	17/329 (5.2%)

Most frequent serious events

Most frequent serious events
Event	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
Head injuryInjury, poisoning and procedural complications	0/331	1/323	0/332	0/329
Drug eruptionSkin and subcutaneous tissue disorders	0/331	1/323	0/332	0/329
HypertensionVascular disorders	0/331	0/323	0/332	1/329
Varicose veinVascular disorders	1/331	0/323	0/332	0/329
Chest painGeneral disorders	0/331	0/323	1/332	0/329
Medical device complicationInjury, poisoning and procedural complications	0/331	0/323	1/332	0/329
Cerebral haemorrhageNervous system disorders	0/331	0/323	1/332	0/329

Most frequent other events

Most frequent other events
Event	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg
CoughRespiratory, thoracic and mediastinal disorders	4/331	3/323	2/332	17/329

Baseline characteristics

Age Continuous
Age Continuous(years)	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg	Total
Mean	53.8 ± 9.45	53.3 ± 10.53	52.7 ± 10.22	52.9 ± 9.60	53.2 ± 9.95

Age, Customized
Age, Customized(Participants)	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg	Total
< 65 years	288	273	285	296	1142
≥ 65 years	43	50	47	34	174

Sex: Female, Male
Sex: Female, Male(Participants)	Aliskiren 300 mg	Aliskiren 150 mg	Aliskiren 75 mg	Ramipril 5 mg	Total
Female	150	140	144	151	585
Male	181	183	188	179	731

Study locations

3 sites

Novartis Investigative Sites
China, China
Novartis Investigative Sites
India, India
Novartis Investigative Sites
Thailand, Thailand

References and documents

Publications

Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2. PubMed 33089502 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2007, a primary completion of Jul 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2011, 2 years 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 12, 2007
First posted: Sep 14, 2007
Start: Sep 2007
Primary completionActual: Jul 2008
CompletionActual: Jul 2008
Results first posted: Mar 25, 2011
Last update: Mar 25, 2011

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00529451
Lead sponsor: Novartis
First posted: Sep 14, 2007
Start date: Sep 2007
Primary completion: Jul 2008
Completion: Jul 2008
Results posted: Mar 25, 2011
Last update: Mar 25, 2011

Study contacts

Novartis

study chair · Novartis

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Aliskiren

Other studies in this condition

Hypertension →

Other studies from this sponsor

Novartis →

Start the discussion

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

Study summary

Conditions studied

Browse trials for

Keywords

In context

Hypertension

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Timeline

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria