A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219115

Enrollment

493

Registered

2005-09-22

Start date

2005-01-31

Completion date

2006-03-31

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

Hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide

Brief summary

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.

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 with body mass index ≥ 30 kg/m2

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8	—
Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8	—
Change from baseline in mean sitting systolic blood pressure after 8 weeks	—
Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8	—

Countries

Germany, United States

Outcome results

None listed

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