Phase 4 Completed N=506 Randomized Triple-blind Treatment

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

Hypertension

Source: ClinicalTrials.gov NCT01042392 ↗

Enrolled (actual)

506

Serious AEs

0.5%

Results posted

Apr 2012

Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) — -18.80; -20.78 mmHg

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	-18.80; -20.78	—
SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	-5.23; -6.39	—
SECONDARY Percentage of Patients With Controlled Blood Pressure	36.7; 40.1; 26.8; 32.4	—
SECONDARY 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	3; 9	—
SECONDARY Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)	-19.42; -19.75; -5.37; -5.60	—
SECONDARY Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8	33.6; 35.5	—
SECONDARY Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)	-19.7; -16.9; -19.2; -20.5; -18.1; -19.8	—
SECONDARY 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	-0.50; -1.28; 0.52; 3.27; 0.76; 0.32	—
SECONDARY Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)	55; 43; 3; 1; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01042392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.