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

A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension

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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Actual): 556
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Investigative Site, Belgium
    • Investigator Site
• Denmark
  • Investigative Center, Denmark
    • Investigative Center
• Finland
  • Investigative Site, Finland
    • Investigative Site
• Germany
  • Investigative Center, Germany
    • Investigative Center
• Iceland
  • Investigative Site, Iceland
    • Investigative Site
• India
  • Investigative Site, India
    • Investigative Site
• Switzerland
  • Investigative Site, Switzerland
    • Investigative Site
• United States
  • New Mexico
    • Santa Fe, New Mexico, United States
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aliskiren/Amlodipine	Drug: Aliskiren; All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration; Drug: Amlodipine; All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
Experimental: Aliskiren/Amlodipine/HCTZ	Drug: Aliskiren; All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration; Drug: Amlodipine; All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration; Drug: Hydrochlorothiazide; Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Percentage of Patients With Adverse Events	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Blood Pressure Control Target of <140/90 mmHg	Baseline, Week 2, Week 10, Week 28 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

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

General Publications

• Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: November 18, 2006
• First Submitted That Met QC Criteria: November 20, 2006
• First Posted (Estimate): November 22, 2006

Study Record Updates

• Last Update Posted (Estimate): March 10, 2011
• Last Update Submitted That Met QC Criteria: March 8, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension, aliskiren, amlodipine, HCTZ, blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sodium Chloride Symporter Inhibitors; Amlodipine; Hydrochlorothiazide
• Other Study ID Numbers: CSPA100A2301