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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren; Drug: Hydrochlorothiazide

• Registration Number: NCT00760266
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2010-12-22
• Results First Submitted QC: 2010-12-22
• Results First Posted: 2011-01-21
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 451

Inclusion Criteria

1. Male or female outpatients, ≥ 55 years old
2. Patients with essential hypertension
3. Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 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 (New York Heart Association [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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren/HCTZ 300/25 mg	Aliskiren	-
HCTZ 25 mg	Hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4	Baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders at Week 4 and Week 8	At 4 weeks and 8 weeks	Responders defined as mean sitting Systolic Blood Pressure \< 140 mmHg or reduction of ≥ 20 mmHg from baseline
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8	Baseline and Week 8
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4	Baseline and Week 4
Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8	At Weeks 4 and 8	Blood pressure control defined as mean sitting Systolic Blood Pressure \< 140 mm Hg and mean sitting Diastolic Blood Pressure \< 90 mm Hg

Trial Locations

Locations (1)

Sites in USA; 🇺🇸 East Hanover, New Jersey, United States