Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262236

Enrollment

693

Registered

2005-12-06

Start date

2005-11-30

Completion date

2006-08-31

Last updated

2016-11-18

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

Conditions

Hypertension

Keywords

Hypertension, Aliskiren, Atenolol, Blood Pressure

Brief summary

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.

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

1. Outpatients 18 years of age and older. 2. Patients with essential hypertension.

Exclusion criteria

Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation, Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic blood pressure after 12 weeks	—

Secondary

Measure	Time frame
Change from baseline in systolic blood pressure after 12 weeks	—
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks	—
Blood pressure of < 140/90 mmHg after 12 weeks	—

Countries

Germany, Switzerland

Outcome results

None listed

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