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NCT00262236 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00262236
Other study ID # CSPP100A2304
Secondary ID
Status Completed
Phase Phase 3
First received December 2, 2005
Last updated November 16, 2016
Start date November 2005
Est. completion date August 2006

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 693
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aliskiren

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Dietz R, Dechend R, Yu CM, Bheda M, Ford J, Prescott MF, Keefe DL. Effects of the direct renin inhibitor aliskiren and atenolol alone or in combination in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2008 Sep;9(3):163-75. doi: 10.1177 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in diastolic blood pressure after 12 weeks
Secondary Change from baseline in systolic blood pressure after 12 weeks
Secondary Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
Secondary Blood pressure of < 140/90 mmHg after 12 weeks
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