Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387517

Enrollment

726

Registered

2006-10-13

Start date

2006-10-31

Completion date

2007-08-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Diastolic, systolic, hypertension, aliskiren, blood pressure, hydrochlorothiazide, HCTZ

Brief summary

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

Interventions

DRUGAliskiren/HCTZ

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female outpatients 18 years old or older. * Patients with a diagnosis of hypertension defined as follows: * Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= mmHg and \< 110 mmHg at Visit 1. * All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= 85 mmHg and \< 110 mmHg at Visit 2. * All patients must have a msDBP \>= 90 mmHg and \< 110 mmHg at Visit 5. * Patients who are eligible and consent to participate in the study

Exclusion criteria

* Severe hypertension (msDBP \>= 110 mmHg and/or MSSBP \>=180 mmHg). * Previous or current diagnosis of heart failure. * History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention. * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.	—

Secondary

Measure	Time frame
Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8	—
Safety and tolerability	—
Proportion of patients achieving a blood pressure control target at week 8	—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026