Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

• Registration Number: NCT01113047
• Lead Sponsor: Novartis

Brief Summary

This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Study Start: 2010-05
• Primary Completion: 2010-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

• Essential hypertension stage II
• Male and female patients
• Age >= 18 years old

Read More

Exclusion Criteria

• Severe hypertension (systolic BP >= 180 mmHg, diastolic BP >= 110 mmHg
• Poorly controlled diabetes mellitus or type 1 DM
• History of myocardial infarction, stroke
• Presence of heart failure
• Other protocol-defined inclusion/exclusion criteria may apply

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non responder Olmesartan/Amlodipine	Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ	Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Primary Outcome Measures

Name	Time	Method
Change in mean sitting diastolic blood pressure after 4 weeks of treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT	4 weeks
Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT	4 weeks
Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT	4 weeks

Trial Locations

Locations (1)

Investigative Site; 🇩🇪 Pirna, Germany