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OpenTrials
Completed

NCT Number: NCT00402103

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

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).

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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

Investigator Site, Investigative Site, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aliskiren

Drug

All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

Amlodipine

Drug

All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

Hydrochlorothiazide

Drug

Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Primary outcomes

  1. Overall Percentage of Patients With Adverse Events

    Time frame: 52 weeks

Secondary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54

  2. Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg

    Time frame: Baseline, Week 2, Week 10, Week 28 and Week 54

  3. Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)

    Time frame: Baseline, Week 2, Week 10, Week 28 and Week 54

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2006
Registry last updated
Mar 10, 2011

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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