Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

An 8 Week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219024

Enrollment

2775

Registered

2005-09-22

Start date

2004-08-31

Completion date

2005-06-30

Last updated

2017-05-17

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

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, hydrochlorothiazide (HCTZ).

Brief summary

To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)

Interventions

DRUGaliskiren

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

* Patients with essential hypertension * Patients who are eligible and able to participate in the study

Exclusion criteria

* Severe hypertension * History or evidence of a secondary form of hypertension * History of hypertensive encephalopathy or cerebrovascular accident Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic blood pressure after 8 weeks	—

Secondary

Measure	Time frame
Change from baseline in systolic blood pressure after 8 weeks	—
Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks	—
Blood pressure < 140/90 mmHg	—
Change from baseline in standing diastolic blood pressure after 8 weeks	—
Change from baseline in standing systolic blood pressure after 8 weeks	—

Countries

Germany, United States

Outcome results

None listed

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