A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386139

Enrollment

881

Registered

2006-10-11

Start date

2006-09-30

Completion date

2007-07-31

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

Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

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. * Patients who are eligible and consent to participate in the study

Exclusion criteria

* Severe hypertension * Previous or current diagnosis of heart failure. * History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). * 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