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

September 20, 2016 updated by: Novartis

A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

847

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Investigative Site
  • Germany
      • Berlin, Germany
        • Investigative Site
  • Norway
      • Oslo, Norway
        • Investigative Site
  • Poland
      • Warsaw, Poland
        • Investigative Site
  • Slovakia
      • Bratislava, Slovakia
        • Investigative Site
  • Sweden
      • Stockholm, Sweden
        • Investigative Site
  • Turkey
      • Ankara, Turkey
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlodipine 10 mg
Drug: Amlodipine 10 mg
Amlodipine 10 mg
Experimental: Aliskiren/Amlodipine 150/10 mg
Drug: Amlodipine 10 mg
Amlodipine 10 mg
Drug: Aliskiren 150
Aliskiren/Amlodipine 150/10 mg
Experimental: Aliskiren/Amlodipine 300/10 mg
Drug: Amlodipine 10 mg
Amlodipine 10 mg
Drug: Amlodipine 300
Aliskiren/Amlodipine 300/10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Time Frame: Baseline and Week 8
Baseline and Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, N

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPA100A2304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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