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NCT00219167 Clinical Trial

A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Hypertension Clinical Trial

Official title:
An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219167
Other study ID # CSPP100A2324
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated November 16, 2016
Start date April 2005
Est. completion date February 2006

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

Recruitment information / eligibility
Status Completed
Enrollment 355
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria

- Patients with at least 65 years-old

- Patients with essential hypertension Exclusion Criteria

- Severe hypertension

- History or evidence of a secondary form of hypertension

- History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• aliskiren

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Verdecchia P, Calvo C, Möckel V, Keeling L, Satlin A. Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension. Blood Press. 2007;16(6):381-91. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
Secondary Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks
Secondary Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks
Secondary Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks
Secondary Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks
Secondary Blood pressure control target of < 140/90 mmHg after 8 weeks
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