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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Aliskiren (Drug); Ramipril (Drug); Matching placebo to Aliskiren (Drug); Matching placebo to Ramipril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Secondary outcome:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Percentage of Patients With Controlled Blood Pressure

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

Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)

Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8

Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)

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

Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Aire Sur Adour, France

Novartis Investigative Site, Amboise, France

Novartis Investigative Site, Angers, France

Novartis Investigative Site, Anzin, France

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Additional Information

Starting date: November 2009
Last updated: March 6, 2012

Page last updated: August 23, 2015

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