An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide

• Registration Number: NCT00402103
• Lead Sponsor: Novartis

Brief Summary

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-18
• Study First Submitted QC: 2006-11-20
• Study First Posted: 2006-11-22
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2010-12-13
• Results First Submitted QC: 2010-12-13
• Results First Posted: 2011-01-11
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-08
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Outpatients 18 years of age or older
• Male or female patients are eligible
• For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
• For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)

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 may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aliskiren/Amlodipine	Aliskiren	-
Aliskiren/Amlodipine	Amlodipine	-
Aliskiren/Amlodipine/HCTZ	Amlodipine	-
Aliskiren/Amlodipine/HCTZ	Aliskiren	-
Aliskiren/Amlodipine/HCTZ	Hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Overall Percentage of Patients With Adverse Events	52 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg	Baseline, Week 2, Week 10, Week 28 and Week 54
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points	Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline, Week 2, Week 10, Week 28 and Week 54

Trial Locations

Locations (3)

Investigative Center; 🇩🇪 Investigative Center, Germany

Investigator Site; 🇧🇪 Investigative Site, Belgium

Investigative Site; 🇨🇭 Investigative Site, Switzerland