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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Aliskiren
Ramipril
Matching placebo to Aliskiren
Matching placebo to Ramipril
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Moderate systolic hypertension - adults - aliskiren -ramipril

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigator Site
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  • Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Ramipril

Aliskiren

Placebo to Ramipril

Placebo to Aliskiren

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
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.

Secondary Outcome Measures

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
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.
Percentage of Patients With Controlled Blood Pressure
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.
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
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.
Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)
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.
Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8
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.
Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)
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%.
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
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.
Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)
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.

Full Information

First Posted
January 1, 2010
Last Updated
March 6, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01042392
Brief Title
Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Acronym
ALIAS
Official Title
Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Moderate systolic hypertension - adults - aliskiren -ramipril

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramipril
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Aliskiren
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo to Ramipril
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Placebo to Aliskiren
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Intervention Description
150 mg Aliskiren as film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
Ramipril 5 mg was given in capsule form.
Intervention Type
Drug
Intervention Name(s)
Matching placebo to Aliskiren
Intervention Description
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
Intervention Name(s)
Matching placebo to Ramipril
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Description
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.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Description
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.
Time Frame
Baseline to 8 weeks
Title
Percentage of Patients With Controlled Blood Pressure
Description
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.
Time Frame
At 4 and 8 weeks
Title
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
Description
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.
Time Frame
After 8 weeks
Title
Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)
Description
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.
Time Frame
Baseline to 4 weeks
Title
Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8
Description
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.
Time Frame
At week 8
Title
Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)
Description
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%.
Time Frame
Baseline to 8 weeks
Title
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
Description
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.
Time Frame
From 8 weeks to 48 hours after week 8
Title
Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)
Description
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.
Time Frame
8 weeks + 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aire Sur Adour
Country
France
Facility Name
Novartis Investigative Site
City
Amboise
Country
France
Facility Name
Novartis Investigative Site
City
Angers
Country
France
Facility Name
Novartis Investigative Site
City
Anzin
Country
France
Facility Name
Novartis Investigative Site
City
Bachant
Country
France
Facility Name
Novartis Investigative Site
City
Bandol
Country
France
Facility Name
Novartis Investigative Site
City
Becon-les-granits
Country
France
Facility Name
Novartis Investigative Site
City
Bersee
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
Country
France
Facility Name
Novartis Investigative Site
City
Bouliac
Country
France
Facility Name
Novartis Investigative Site
City
Bourges
Country
France
Facility Name
Novartis Investigative Site
City
Briollay
Country
France
Facility Name
Novartis Investigative Site
City
Bruges
Country
France
Facility Name
Novartis Investigative Site
City
Caen
Country
France
Facility Name
Novartis Investigative Site
City
Carbonne
Country
France
Facility Name
Novartis Investigative Site
City
Chatellerault
Country
France
Facility Name
Novartis Investigative Site
City
Chatillon Sur Colmon
Country
France
Facility Name
Novartis Investigative Site
City
Cherbourg
Country
France
Facility Name
Novartis Investigative Site
City
Château Gontier
Country
France
Facility Name
Novartis Investigative Site
City
Château-gontier
Country
France
Facility Name
Novartis Investigative Site
City
Cournonterral
Country
France
Facility Name
Novartis Investigative Site
City
Croix
Country
France
Facility Name
Novartis Investigative Site
City
Cugnaux
Country
France
Facility Name
Novartis Investigative Site
City
Ecouflant
Country
France
Facility Name
Novartis Investigative Site
City
Equeurdreville
Country
France
Facility Name
Novartis Investigative Site
City
Falaise
Country
France
Facility Name
Novartis Investigative Site
City
Fondettes
Country
France
Facility Name
Novartis Investigative Site
City
Guerigny
Country
France
Facility Name
Novartis Investigative Site
City
Hautmont
Country
France
Facility Name
Novartis Investigative Site
City
L'aigle
Country
France
Facility Name
Novartis Investigative Site
City
La Farlede
Country
France
Facility Name
Novartis Investigative Site
City
La Riche
Country
France
Facility Name
Novartis Investigative Site
City
La Rochelle
Country
France
Facility Name
Novartis Investigative Site
City
Labarthe Sur Leze
Country
France
Facility Name
Novartis Investigative Site
City
Lambersart
Country
France
Facility Name
Novartis Investigative Site
City
Laval
Country
France
Facility Name
Novartis Investigative Site
City
Le Bouscat
Country
France
Facility Name
Novartis Investigative Site
City
Le Cailar
Country
France
Facility Name
Novartis Investigative Site
City
Le Fousseret
Country
France
Facility Name
Novartis Investigative Site
City
Le Pradet
Country
France
Facility Name
Novartis Investigative Site
City
Les Maguelone
Country
France
Facility Name
Novartis Investigative Site
City
Luynes
Country
France
Facility Name
Novartis Investigative Site
City
Marcheprime
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
Country
France
Facility Name
Novartis Investigative Site
City
Marsilly
Country
France
Facility Name
Novartis Investigator Site
City
Marsilly
Country
France
Facility Name
Novartis Investigative Site
City
Mayenne
Country
France
Facility Name
Novartis Investigative Site
City
Medis
Country
France
Facility Name
Novartis Investigative Site
City
Mont-de-marsan
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
Country
France
Facility Name
Novartis Investigative Site
City
Montrevault
Country
France
Facility Name
Novartis Investigative Site
City
Monts sur guesnes
Country
France
Facility Name
Novartis Investigative Site
City
Mortagne-sur-sevre
Country
France
Facility Name
Novartis Investigative Site
City
Mourmelon-le-petit
Country
France
Facility Name
Novartis Investigative Site
City
Nantes
Country
France
Facility Name
Novartis Investigative Site
City
Nevers
Country
France
Facility Name
Novartis Investigative Site
City
Nieul sur mer
Country
France
Facility Name
Novartis Investigative Site
City
Orchies
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
Facility Name
Novartis Investigative Site
City
Perigny
Country
France
Facility Name
Novartis Investigative Site
City
Potigny
Country
France
Facility Name
Novartis Investigative Site
City
Reims
Country
France
Facility Name
Novartis Investigative Site
City
Roquevaire
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
Country
France
Facility Name
Novartis Investigative Site
City
Saint Avertin
Country
France
Facility Name
Novartis Investigative Site
City
Saint Benoit
Country
France
Facility Name
Novartis Investigative Site
City
Saint Germain de marencennes
Country
France
Facility Name
Novartis Investigative Site
City
Saint loubes
Country
France
Facility Name
Novartis Investigative Site
City
Saint Rogatien
Country
France
Facility Name
Novartis Investigative Site
City
Saint Xandre
Country
France
Facility Name
Novartis Investigative Site
City
Saint-CYR-SUR-MER
Country
France
Facility Name
Investigative Site
City
Saint-orens-de-gameville
Country
France
Facility Name
Novartis Investigative Site
City
Saint-orens-de-gameville
Country
France
Facility Name
Novartis Investigative Site
City
Sainte marie de re
Country
France
Facility Name
Novartis Investigative Site
City
Sanary sur mer
Country
France
Facility Name
Novartis Investigative Site
City
Savonnieres
Country
France
Facility Name
Novartis Investigative Site
City
Scorbe clairvaux
Country
France
Facility Name
Investigative Site
City
Scorbe-clairvaux
Country
France
Facility Name
Novartis Investigative Site
City
Segre
Country
France
Facility Name
Novartis Investigative Site
City
Seysses
Country
France
Facility Name
Novartis Investigative Site
City
Sotteville les rouen
Country
France
Facility Name
Novartis Investigative Site
City
ST Cyr Sur Loire
Country
France
Facility Name
Novartis Investigative Site
City
St Georges D'Orques
Country
France
Facility Name
Novartis Investigative Site
City
St Martin D'Oney
Country
France
Facility Name
Novartis Investigative Site
City
St Seurin De Cursac
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg
Country
France
Facility Name
Novartis Investigative Site
City
Thun St Amand
Country
France
Facility Name
Novartis Investigative Site
City
Tierce
Country
France
Facility Name
Investigative Site
City
Toulon
Country
France
Facility Name
Novartis Investigative Site
City
Toulon
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
Country
France
Facility Name
Novartis Investigative Site
City
Tours
Country
France
Facility Name
Novartis Investigative Site
City
Trelaze
Country
France
Facility Name
Novartis Investigative Site
City
Vendome
Country
France
Facility Name
Novartis Investigative Site
City
Vereneque
Country
France
Facility Name
Novartis Investigative Site
City
Verzy
Country
France
Facility Name
Novartis Investigative Site
City
Vierzon
Country
France
Facility Name
Novartis Investigative Site
City
Vieux Conde
Country
France
Facility Name
Novartis Investigative Site
City
Witry-Les-Reims
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33089502
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.
Results Reference
derived

Learn more about this trial

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

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