Clinical trial NCT01042392: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Official title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Moderate systolic hypertension - adults - aliskiren -ramipril
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-05
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to 8 weeks
measure: Percentage of Patients With Controlled Blood Pressure
timeFrame: At 4 and 8 weeks
measure: Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night
timeFrame: After 8 weeks
measure: Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)
timeFrame: Baseline to 4 weeks
measure: Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8
timeFrame: At week 8
measure: Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)
timeFrame: Baseline to 8 weeks
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose
timeFrame: From 8 weeks to 48 hours after week 8
measure: Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)
timeFrame: 8 weeks + 1 day
Other outcomes:
Locations:
city: Aire Sur Adour
country: France
facility: Novartis Investigative Site
city: Amboise
country: France
facility: Novartis Investigative Site
city: Angers
country: France
facility: Novartis Investigative Site
city: Anzin
country: France
facility: Novartis Investigative Site
city: Bachant
country: France
facility: Novartis Investigative Site
city: Bandol
country: France
facility: Novartis Investigative Site
city: Becon-les-granits
country: France
facility: Novartis Investigative Site
city: Bersee
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bouliac
country: France
facility: Novartis Investigative Site
city: Bourges
country: France
facility: Novartis Investigative Site
city: Briollay
country: France
facility: Novartis Investigative Site
city: Bruges
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Carbonne
country: France
facility: Novartis Investigative Site
city: Chatellerault
country: France
facility: Novartis Investigative Site
city: Chatillon Sur Colmon
country: France
facility: Novartis Investigative Site
city: Cherbourg
country: France
facility: Novartis Investigative Site
city: Château Gontier
country: France
facility: Novartis Investigative Site
city: Château-gontier
country: France
facility: Novartis Investigative Site
city: Cournonterral
country: France
facility: Novartis Investigative Site
city: Croix
country: France
facility: Novartis Investigative Site
city: Cugnaux
country: France
facility: Novartis Investigative Site
city: Ecouflant
country: France
facility: Novartis Investigative Site
city: Equeurdreville
country: France
facility: Novartis Investigative Site
city: Falaise
country: France
facility: Novartis Investigative Site
city: Fondettes
country: France
facility: Novartis Investigative Site
city: Guerigny
country: France
facility: Novartis Investigative Site
city: Hautmont
country: France
facility: Novartis Investigative Site
city: L'aigle
country: France
facility: Novartis Investigative Site
city: La Farlede
country: France
facility: Novartis Investigative Site
city: La Riche
country: France
facility: Novartis Investigative Site
city: La Rochelle
country: France
facility: Novartis Investigative Site
city: Labarthe Sur Leze
country: France
facility: Novartis Investigative Site
city: Lambersart
country: France
facility: Novartis Investigative Site
city: Laval
country: France
facility: Novartis Investigative Site
city: Le Bouscat
country: France
facility: Novartis Investigative Site
city: Le Cailar
country: France
facility: Novartis Investigative Site
city: Le Fousseret
country: France
facility: Novartis Investigative Site
city: Le Pradet
country: France
facility: Novartis Investigative Site
city: Les Maguelone
country: France
facility: Novartis Investigative Site
city: Luynes
country: France
facility: Novartis Investigative Site
city: Marcheprime
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Marsilly
country: France
facility: Novartis Investigative Site
city: Marsilly
country: France
facility: Novartis Investigator Site
city: Mayenne
country: France
facility: Novartis Investigative Site
city: Medis
country: France
facility: Novartis Investigative Site
city: Mont-de-marsan
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Montrevault
country: France
facility: Novartis Investigative Site
city: Monts sur guesnes
country: France
facility: Novartis Investigative Site
city: Mortagne-sur-sevre
country: France
facility: Novartis Investigative Site
city: Mourmelon-le-petit
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Nevers
country: France
facility: Novartis Investigative Site
city: Nieul sur mer
country: France
facility: Novartis Investigative Site
city: Orchies
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Perigny
country: France
facility: Novartis Investigative Site
city: Potigny
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Roquevaire
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint Avertin
country: France
facility: Novartis Investigative Site
city: Saint Benoit
country: France
facility: Novartis Investigative Site
city: Saint Germain de marencennes
country: France
facility: Novartis Investigative Site
city: Saint loubes
country: France
facility: Novartis Investigative Site
city: Saint Rogatien
country: France
facility: Novartis Investigative Site
city: Saint Xandre
country: France
facility: Novartis Investigative Site
city: Saint-CYR-SUR-MER
country: France
facility: Novartis Investigative Site
city: Saint-orens-de-gameville
country: France
facility: Investigative Site
city: Saint-orens-de-gameville
country: France
facility: Novartis Investigative Site
city: Sainte marie de re
country: France
facility: Novartis Investigative Site
city: Sanary sur mer
country: France
facility: Novartis Investigative Site
city: Savonnieres
country: France
facility: Novartis Investigative Site
city: Scorbe clairvaux
country: France
facility: Novartis Investigative Site
city: Scorbe-clairvaux
country: France
facility: Investigative Site
city: Segre
country: France
facility: Novartis Investigative Site
city: Seysses
country: France
facility: Novartis Investigative Site
city: Sotteville les rouen
country: France
facility: Novartis Investigative Site
city: ST Cyr Sur Loire
country: France
facility: Novartis Investigative Site
city: St Georges D'Orques
country: France
facility: Novartis Investigative Site
city: St Martin D'Oney
country: France
facility: Novartis Investigative Site
city: St Seurin De Cursac
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Thun St Amand
country: France
facility: Novartis Investigative Site
city: Tierce
country: France
facility: Novartis Investigative Site
city: Toulon
country: France
facility: Investigative Site
city: Toulon
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Trelaze
country: France
facility: Novartis Investigative Site
city: Vendome
country: France
facility: Novartis Investigative Site
city: Vereneque
country: France
facility: Novartis Investigative Site
city: Verzy
country: France
facility: Novartis Investigative Site
city: Vierzon
country: France
facility: Novartis Investigative Site
city: Vieux Conde
country: France
facility: Novartis Investigative Site
city: Witry-Les-Reims
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.