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Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

NCT ID: NCT01042392

Last Updated: 2012-04-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-01-31

Brief Summary

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This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ramipril

In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.

In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.

In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

Ramipril 5 mg was given in capsule form.

Matching placebo to Aliskiren

Intervention Type DRUG

The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.

Aliskiren

In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.

In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.

In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

150 mg Aliskiren as film-coated tablet

Matching placebo to Ramipril

Intervention Type DRUG

The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Placebo to Ramipril

In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Group Type PLACEBO_COMPARATOR

Matching placebo to Ramipril

Intervention Type DRUG

The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Placebo to Aliskiren

In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Group Type PLACEBO_COMPARATOR

Matching placebo to Aliskiren

Intervention Type DRUG

The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.

Interventions

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Aliskiren

150 mg Aliskiren as film-coated tablet

Intervention Type DRUG

Ramipril

Ramipril 5 mg was given in capsule form.

Intervention Type DRUG

Matching placebo to Aliskiren

The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.

Intervention Type DRUG

Matching placebo to Ramipril

The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients \> 18 years
* Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
* Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
* BP thresholds at visit 1:

* For patients previously treated and uncontrolled: 140≤ office SBP\<180 mmHg
* For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
* BP thresholds at visit 2 (for all patients):

* 160≤office SBP\<180 mmHg AND
* 155≤home SBP\<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

Exclusion Criteria

* Women of child-bearing potential not using any effective methods of contraception
* Severe hypertension (office BP ≥ 180/110 mmHg)
* Impossibility to stop abruptly previous antihypertensive treatments at visit 1
* Patients previously untreated or patients treated with two or three antihypertensive medications
* History or evidence of a secondary form of hypertension
* History of hypersensitivity to ACEi or renin inhibitors
* History of heart failure, stroke or coronary heart disease
* Serum potassium ≥ 5.2 mmol/l
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Aire Sur Adour, , France

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Novartis Investigative Site

Amboise, , France

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Angers, , France

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Anzin, , France

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Bachant, , France

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Bandol, , France

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Bersée, , France

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Bécon-les-Granits, , France

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Bordeaux, , France

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Bouliac, , France

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Bourges, , France

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Briollay, , France

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Bruges, , France

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Caen, , France

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Carbonne, , France

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Chatillon Sur Colmon, , France

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Château-Gontier, , France

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Châtellerault, , France

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Cherbourg, , France

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Cournonterral, , France

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Croix, , France

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Cugnaux, , France

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Écouflant, , France

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Équeurdreville-Hainneville, , France

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Falaise, , France

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Fondettes, , France

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Guérigny, , France

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Hautmont, , France

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L'Aigle, , France

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La Farlède, , France

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La Riche, , France

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La Rochelle, , France

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Labarthe-sur-Lèze, , France

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Lambersart, , France

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Laval, , France

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Le Bouscat, , France

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Le Fousseret, , France

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Le Pradet, , France

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Les Maguelone, , France

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Luynes, , France

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Marcheprime, , France

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Marseille, , France

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Marsilly, , France

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Marsilly, , France

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Mayenne, , France

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Médis, , France

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Mont-de-Marsan, , France

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Montpellier, , France

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Montrevault, , France

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Monts-sur-Guesnes, , France

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Mortagne-sur-Sèvre, , France

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Mourmelon-le-Petit, , France

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Nantes, , France

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Nevers, , France

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Nieul-sur-Mer, , France

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Orchies, , France

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Paris, , France

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Périgny, , France

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Potigny, , France

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Reims, , France

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Roquevaire, , France

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Rouen, , France

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Saint-Avertin, , France

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Saint-Benoît, , France

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Saint-Cyr-sur-Loire, , France

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Saint-Cyr-sur-Mer, , France

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Saint-Georges-dOrques, , France

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Saint-Germain-de-Marencennes, , France

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Saint-Loubès, , France

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Saint-Martin-d'Oney, , France

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Saint-Orens-de-Gameville, , France

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Saint-Orens-de-Gameville, , France

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Saint-Rogatien, , France

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Saint-Seurin-de-Cursac, , France

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Saint-Xandre, , France

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Sainte-Marie-de-Ré, , France

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Sanary-sur-Mer, , France

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Savonnières, , France

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Scorbé-Clairvaux, , France

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Segré, , France

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Seysses, , France

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Sotteville-lès-Rouen, , France

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Strasbourg, , France

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Thun-Saint-Amand, , France

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Tiercé, , France

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Toulon, , France

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Toulon, , France

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Toulouse, , France

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Tours, , France

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Trélazé, , France

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Vendôme, , France

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Vereneque, , France

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Verzy, , France

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Vierzon, , France

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Vieux-Condé, , France

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Witry-lès-Reims, , France

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Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33089502 (View on PubMed)

Other Identifiers

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2009-011296-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSPP100AFR01

Identifier Type: -

Identifier Source: org_study_id

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