A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219089

Enrollment

839

Registered

2005-09-22

Start date

2004-11-30

Completion date

2005-08-31

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, Diabetes Mellitus

Keywords

Hypertension, aliskiren, blood pressure, diabetes mellitus, ramipril

Brief summary

To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

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 a documented diagnosis of Type 1 or Type 2 diabetes mellitus. * 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 8 weeks	—

Secondary

Measure	Time frame
Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure	—
Change from baseline to week 8 endpoint in mean sitting systolic blood pressure	—
Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks	—

Countries

Germany, United States

Outcome results

None listed

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