A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension

Hypertension Clinical Trial

Official title:

An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219050
• Other study ID #: CSPP100A2303
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 24, 2011
• Start date: February 2005
• Est. completion date: November 2005

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patients with essential severe hypertension Exclusion Criteria

• History or evidence of a secondary form of hypertension

• History of hypertensive encephalopathy or cerebrovascular accident.

• Diabetic patients requiring insulin 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

• Hypertension

Intervention

Drug:
• aliskiren

Locations

Country	Name	City	State
Germany	Investigative Site	Berlin
Hungary	Investigative Site	Budapest
Spain	Investigative Site	Madrid
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Hungary,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
Secondary	Change from baseline in diastolic blood pressure after 8 weeks
Secondary	Change from baseline in systolic blood pressure after 8 weeks
Secondary	Change from baseline in standing systolic blood and diastolic pressure after 8 weeks
Secondary	Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks