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OpenTrials
Completed

NCT Number: NCT00219076

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

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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 Centers, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with essential hypertension
  • Patients who are eligible and able to participate in the study Exclusion Criteria
  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure after 6 weeks

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure after 6 weeks

  2. Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks

  3. Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks

  4. Change from baseline in standing diastolic blood pressure after 6 weeks

  5. Change from baseline in standing systolic blood pressure after 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Six-week, Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren 150 mg and Amlodipine 5 mg Compared to Amlodipine 5 mg and 10 mg in Hypertensive Patients Not Adequately Responsive to Amlodipine 5 mg

Important dates

Study start
2005
Primary completion
2005
First posted
Sep 22, 2005
Registry last updated
May 18, 2017

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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