Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Amlodipine 10 mg; Drug: Aliskiren 150; Drug: Amlodipine 300

• Registration Number: NCT00778921
• Lead Sponsor: Novartis

Brief Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-12-13
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-25
• Results First Posted: 2011-03-23
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 847

Inclusion Criteria

• Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
• Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
• All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)

Exclusion Criteria

• Severe hypertension
• Pregnant or nursing (lactating) women
• Pre-menopausal women not taking accepted form of birth control
• Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
• History of cardiovascular conditions
• Uncontrolled Type 1 or Type 2 diabetes mellitus
• Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren/Amlodipine 150/10 mg	Aliskiren 150	Aliskiren/Amlodipine 150/10 mg
Amlodipine 10 mg	Amlodipine 10 mg	Amlodipine 10 mg
Aliskiren/Amlodipine 300/10 mg	Amlodipine 300	Aliskiren/Amlodipine 300/10 mg
Aliskiren/Amlodipine 150/10 mg	Amlodipine 10 mg	Aliskiren/Amlodipine 150/10 mg
Aliskiren/Amlodipine 300/10 mg	Amlodipine 10 mg	Aliskiren/Amlodipine 300/10 mg

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study	Baseline and Week 8

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group	8 weeks
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study	Baseline and Week 8
Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)	12 weeks

Trial Locations

Locations (1)

Investigative Site; 🇹🇷 Ankara, Turkey