Clinical trial NCT00529451: Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
Official title: An Eight Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, Aliskiren, Ramipril
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 1613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \< 110 mmHg at the visit immediately prior to Visit 3
* Patients must have msDBP \>OR= 95 mmHg and \< 110 mmHg at Visit 3
* Patients must have an absolute difference of \< or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

* Severe hypertension (grade 3 WHO classification; msDBP \>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.

Primary outcomes:
measure: Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline and Week 8
measure: Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline and Week 8
measure: Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
timeFrame: Baseline and Week 8
measure: 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
timeFrame: Week 8
measure: 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
timeFrame: Week 8
Other outcomes:
Locations:
city: China
country: China
facility: Novartis Investigative Sites
city: India
country: India
facility: Novartis Investigative Sites
city: Thailand
country: Thailand
facility: Novartis Investigative Sites
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
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.