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OpenTrials
Completed

NCT Number: NCT00778921

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine 10 mg

Drug

Amlodipine 10 mg

Aliskiren 150

Drug

Aliskiren/Amlodipine 150/10 mg

Amlodipine 300

Drug

Aliskiren/Amlodipine 300/10 mg

Primary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study

    Time frame: Baseline and Week 8

Secondary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study

    Time frame: Baseline and Week 8

  2. Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group

    Time frame: 8 weeks

  3. Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2008
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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