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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01042392
• Date of registration: 01/01/2010
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients ALIAS
• Scientific title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
• Date of first enrolment: November 2009
• Target sample size: 506
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01042392
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Essential Hypertension

Intervention(s)

Drug: Matching placebo to Ramipril

Drug: Matching placebo to Aliskiren

Drug: Ramipril

Drug: Aliskiren

Primary Outcome(s)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [Time Frame: Baseline to 8 weeks]

Secondary Outcome(s)

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]

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]

Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks) [Time Frame: Baseline to 4 weeks]

Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8 [Time Frame: At week 8]

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [Time Frame: Baseline to 8 weeks]

Percentage of Patients With Controlled Blood Pressure [Time Frame: At 4 and 8 weeks]

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]

Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III) [Time Frame: 8 weeks + 1 day]

Secondary ID(s)

2009-011296-80

CSPP100AFR01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/04/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01042392