Phase 3 N=1,316 Randomized Double-blind Treatment

Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00529451 ↗

Enrolled (actual)

1,316

Serious AEs

0.5%

Results posted

Mar 2011

Primary outcome: Primary: Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) — -11.63; -9.19 mm Hg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Aliskiren (Drug); Ramipril (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	-11.63; -9.19	—
PRIMARY Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	-10.04; -9.19	—
PRIMARY Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)	-10.66; -9.19	—
SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint	-14.39; -12.16; -12.24; -11.46; -11.63; -10.04	—
SECONDARY Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg	52.29; 48.11; 45.68; 43.65	—
SECONDARY Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP	67.89; 59.75; 59.57; 53.87	—

Summary

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

Eligibility Criteria

Inclusion Criteria

Patients must have msDBP ≥ 90 mmHg and OR= 95 mmHg and or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00529451). 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.