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

Last updated: June 30, 2011
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Stress

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00777946
CSPA100A2303
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed patients or patients who have not been treated for hypertension withinthe 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (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 1must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2

  • All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 4

Exclusion

Exclusion Criteria:

  • Severe hypertension

  • Pregnant or nursing (lactating) women

  • Women of child-bearing potential

  • Previous or current diagnosis of heart failure New York Heart Association (NYHA ClassII-IV)

  • Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1

  • Uncontrolled Type 1 or Type 2 diabetes mellitus

  • Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs withSimilar chemical structures

  • History of hypertensive encephalopathy or cerebrovascular accident, or history oftransient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, orany percutaneous coronary intervention Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 818
Study Start date:
October 01, 2008
Estimated Completion Date:
May 31, 2009

Connect with a study center

  • Investigative site

    Estonia,
    Estonia

    Site Not Available

  • Investigative site

    France,
    France

    Site Not Available

  • Investigative Site

    Iceland,
    Iceland

    Site Not Available

  • Investigative Site

    India,
    India

    Site Not Available

  • Investigative site

    Italy,
    Italy

    Site Not Available

  • Investigative Site

    Republic of Korea,
    Korea, Republic of

    Site Not Available

  • Investigative Site

    Lithuania,
    Lithuania

    Site Not Available

  • Investigative Site

    Spain,
    Spain

    Site Not Available

  • Investigative Site

    Venezuela,
    Venezuela

    Site Not Available

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