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OpenTrials
Completed

NCT Number: NCT00219115

A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ 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 Centers, Germany

Loading trial locations.

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 with body mass index ≥ 30 kg/m2

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 also apply.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure after 8 weeks

  2. Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8

  3. Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8

  4. Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Feb 7, 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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