Blood Pressure Lowering of Aliskiren HCTZ Compared HCTZ in Stage 2 Systolic Hypertension in Older Population

Condition(s) targeted: Hypertension

Intervention: Aliskiren HCTZ (Drug); HCTZ (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Overall contact:
Novartis, Phone: 862-778-8300

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren HCTZ compared to HCTZ in older population with Stage 2 systolic hypertension.

Official title: An 8-Week Randomized, Double-Blind, Parallel-Group, Multi-Center, Active-Controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients With Stage 2 Systolic Hypertension

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in msSBP after 8 weeks of treatment

Secondary outcome:

Change in msDBP after 8 weeks of treatment

Efficacy of regimens on msSBP and msDBP

Proportion of responders at week 4 and regimens at week 8

Proportion of patients achieving BP control at week 4 and regimens at week 8

Safety and tolerability of aliskiren HCTZ compared to HCTZ at week 4 and regimens at week 8

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or female outpatients, ³ 55 years old

2. Patients with essential hypertension

3. Prior to randomization: Patients must have an office cuff msSBP ³ 160 mm Hg and < 200 mm Hg

4. Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed

Exclusion Criteria:

1. Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5

2. History or evidence of a secondary hypertension of any etiology (e. g., uncorrected renal artery stenosis, pheochromocytoma).

3. History of hypertensive encephalopathy or heart failure (NYHA Class II-IV)

4. Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1

5. Serum sodium less than the lower limit of normal, serum potassium < 3. 5 mEq/L (corresponding to 3. 5 mmol/L) or ≥ 5. 3 mEq/L (corresponding to 5. 3 mmol/L), or dehydration at Visit 1.

6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)

7. Use of other investigational drugs within 30 days of enrollment.

Other exclusions may apply.

Novartis, Phone: 862-778-8300

Investigative Site, Decatur, Georgia, United States; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Detroit, Michigan, United States; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Bryan, Texas, United States; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Richmond, Virginia, United States; Recruiting
Novartis, Phone: 862-778-8300

Starting date: September 2008
Last updated: October 2, 2008