- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01042392
Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients (ALIAS)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Aire Sur Adour, France
- Novartis Investigative Site
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Amboise, France
- Novartis Investigative Site
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Angers, France
- Novartis Investigative Site
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Anzin, France
- Novartis Investigative Site
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Bachant, France
- Novartis Investigative Site
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Bandol, France
- Novartis Investigative Site
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Becon-les-granits, France
- Novartis Investigative Site
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Bersee, France
- Novartis Investigative Site
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Bordeaux, France
- Novartis Investigative Site
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Bouliac, France
- Novartis Investigative Site
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Bourges, France
- Novartis Investigative Site
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Briollay, France
- Novartis Investigative Site
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Bruges, France
- Novartis Investigative Site
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Caen, France
- Novartis Investigative Site
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Carbonne, France
- Novartis Investigative Site
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Chatellerault, France
- Novartis Investigative Site
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Chatillon Sur Colmon, France
- Novartis Investigative Site
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Cherbourg, France
- Novartis Investigative Site
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Château Gontier, France
- Novartis Investigative Site
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Château-gontier, France
- Novartis Investigative Site
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Cournonterral, France
- Novartis Investigative Site
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Croix, France
- Novartis Investigative Site
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Cugnaux, France
- Novartis Investigative Site
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Ecouflant, France
- Novartis Investigative Site
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Equeurdreville, France
- Novartis Investigative Site
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Falaise, France
- Novartis Investigative Site
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Fondettes, France
- Novartis Investigative Site
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Guerigny, France
- Novartis Investigative Site
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Hautmont, France
- Novartis Investigative Site
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L'aigle, France
- Novartis Investigative Site
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La Farlede, France
- Novartis Investigative Site
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La Riche, France
- Novartis Investigative Site
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La Rochelle, France
- Novartis Investigative Site
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Labarthe Sur Leze, France
- Novartis Investigative Site
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Lambersart, France
- Novartis Investigative Site
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Laval, France
- Novartis Investigative Site
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Le Bouscat, France
- Novartis Investigative Site
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Le Cailar, France
- Novartis Investigative Site
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Le Fousseret, France
- Novartis Investigative Site
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Le Pradet, France
- Novartis Investigative Site
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Les Maguelone, France
- Novartis Investigative Site
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Luynes, France
- Novartis Investigative Site
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Marcheprime, France
- Novartis Investigative Site
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Marseille, France
- Novartis Investigative Site
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Marsilly, France
- Novartis Investigative Site
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Marsilly, France
- Novartis Investigator Site
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Mayenne, France
- Novartis Investigative Site
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Medis, France
- Novartis Investigative Site
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Mont-de-marsan, France
- Novartis Investigative Site
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Montpellier, France
- Novartis Investigative Site
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Montrevault, France
- Novartis Investigative Site
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Monts sur guesnes, France
- Novartis Investigative Site
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Mortagne-sur-sevre, France
- Novartis Investigative Site
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Mourmelon-le-petit, France
- Novartis Investigative Site
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Nantes, France
- Novartis Investigative Site
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Nevers, France
- Novartis Investigative Site
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Nieul sur mer, France
- Novartis Investigative Site
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Orchies, France
- Novartis Investigative Site
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Paris, France
- Novartis Investigative Site
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Perigny, France
- Novartis Investigative Site
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Potigny, France
- Novartis Investigative Site
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Reims, France
- Novartis Investigative Site
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Roquevaire, France
- Novartis Investigative Site
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Rouen, France
- Novartis Investigative Site
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ST Cyr Sur Loire, France
- Novartis Investigative Site
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Saint Avertin, France
- Novartis Investigative Site
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Saint Benoit, France
- Novartis Investigative Site
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Saint Germain de marencennes, France
- Novartis Investigative Site
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Saint Rogatien, France
- Novartis Investigative Site
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Saint Xandre, France
- Novartis Investigative Site
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Saint loubes, France
- Novartis Investigative Site
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Saint-CYR-SUR-MER, France
- Novartis Investigative Site
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Saint-orens-de-gameville, France
- Investigative Site
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Saint-orens-de-gameville, France
- Novartis Investigative Site
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Sainte marie de re, France
- Novartis Investigative Site
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Sanary sur mer, France
- Novartis Investigative Site
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Savonnieres, France
- Novartis Investigative Site
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Scorbe clairvaux, France
- Novartis Investigative Site
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Scorbe-clairvaux, France
- Investigative Site
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Segre, France
- Novartis Investigative Site
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Seysses, France
- Novartis Investigative Site
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Sotteville les rouen, France
- Novartis Investigative Site
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St Georges D'Orques, France
- Novartis Investigative Site
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St Martin D'Oney, France
- Novartis Investigative Site
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St Seurin De Cursac, France
- Novartis Investigative Site
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Strasbourg, France
- Novartis Investigative Site
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Thun St Amand, France
- Novartis Investigative Site
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Tierce, France
- Novartis Investigative Site
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Toulon, France
- Investigative Site
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Toulon, France
- Novartis Investigative Site
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Toulouse, France
- Novartis Investigative Site
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Tours, France
- Novartis Investigative Site
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Trelaze, France
- Novartis Investigative Site
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Vendome, France
- Novartis Investigative Site
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Vereneque, France
- Novartis Investigative Site
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Verzy, France
- Novartis Investigative Site
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Vierzon, France
- Novartis Investigative Site
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Vieux Conde, France
- Novartis Investigative Site
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Witry-Les-Reims, France
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: 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). |
Ramipril 5 mg was given in capsule form.
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.
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EXPERIMENTAL: 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). |
150 mg Aliskiren as film-coated tablet
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.
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PLACEBO_COMPARATOR: 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).
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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.
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PLACEBO_COMPARATOR: 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time Frame: Baseline to 8 weeks
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The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings.
At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device.
The measurements were performed at 1-2 minute intervals.
The mean BP was calculated from the 3 readings.
The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.
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Baseline to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time Frame: Baseline to 8 weeks
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The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings.
At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device.
The measurements were performed at 1-2 minute intervals.
The mean BP was calculated from the 3 readings.
The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable.
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Baseline to 8 weeks
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Percentage of Patients With Controlled Blood Pressure
Time Frame: At 4 and 8 weeks
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The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg. |
At 4 and 8 weeks
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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
Time Frame: After 8 weeks
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Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient.
The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient.
The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time.
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After 8 weeks
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Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)
Time Frame: Baseline to 4 weeks
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The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings.
At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device.
The measurements were performed at 1-2 minute intervals.
The mean BP was calculated from the 3 readings.
The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.
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Baseline to 4 weeks
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Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8
Time Frame: At week 8
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Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient.
The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured.
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At week 8
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Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)
Time Frame: Baseline to 8 weeks
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The sub-groups were: "Riser" = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night.
The "Non-risers" in whom the difference is <55 mmHg.
Patients called "dippers" in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients "non-dippers " in whom this difference was <10%.
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Baseline to 8 weeks
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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
Time Frame: From 8 weeks to 48 hours after week 8
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The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo.
The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.
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From 8 weeks to 48 hours after week 8
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Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)
Time Frame: 8 weeks + 1 day
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Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
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8 weeks + 1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPP100AFR01
- 2009-011296-80 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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