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NCT Number: NCT00219154

A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.

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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

Exclusion criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of myocardial infarction. Other protocol-defined inclusion exclusion criteria also apply

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 26 weeks

Secondary outcomes

  1. Change from baseline systolic blood pressure after 26 weeks

  2. Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 26 weeks

  3. Achieve blood pressure of < 140/90 mmHg after 26 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Nov 8, 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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