A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

A Six-week, Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren 150 mg and Amlodipine 5 mg Compared to Amlodipine 5 mg and 10 mg in Hypertensive Patients Not Adequately Responsive to Amlodipine 5 mg

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219076

Enrollment

504

Registered

2005-09-22

Start date

2005-02-28

Completion date

Unknown

Last updated

2017-05-18

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, amlodipine

Brief summary

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

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 mean sitting diastolic blood pressure after 6 weeks	—

Secondary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure after 6 weeks	—
Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks	—
Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks	—
Change from baseline in standing diastolic blood pressure after 6 weeks	—
Change from baseline in standing systolic blood pressure after 6 weeks	—

Countries

Germany, United States

Outcome results

None listed

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