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Completed

NCT Number: NCT00387517

Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

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Key information

Conditions

Hypertension Cardiovascular Diseases Heart Murmurs Pathological Conditions, Signs and Symptoms Signs and Symptoms Systolic Murmurs 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

  • Male or female outpatients 18 years old or older.
  • Patients with a diagnosis of hypertension defined as follows:
  • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1.
  • All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2.
  • All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5.
  • Patients who are eligible and consent to participate in the study

Exclusion criteria

  • Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
  • Previous or current diagnosis of heart failure.
  • History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Aliskiren/HCTZ

Drug

Primary outcomes

  1. Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.

Secondary outcomes

  1. Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8

  2. Safety and tolerability

  3. Proportion of patients achieving a blood pressure control target at week 8

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 13, 2006
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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