Clinical trial NCT00368277: A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly
Official title: A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Systolic hypertension
hypertension
aliskiren
blood pressure
ramipril
HTN
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 901
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients ≥ 65 years old.
* Patients with essential hypertension with an msSBP ≥ 140 mmHg and \< 180 mmHg, and msDBP \< 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
* Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
* Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).

Exclusion Criteria:

* History of renal artery stenosis.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy.
* Current diagnosis of heart failure (New York Heart Association Class III-IV).
* History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
* History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
* Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
* Clinically significant valvular heart disease.
* Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Patients With Cough
timeFrame: Weeks 12 and 36
measure: Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
timeFrame: Weeks 12 and 36
measure: Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36
timeFrame: Baseline and week 36
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
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.