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OpenTrials
Completed

NCT Number: NCT00219037

Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Completed

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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 Sites, Germany

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. Adverse events, laboratory abnormalities, serious adverse events

Secondary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure after 12 months

  2. Change from baseline in mean sitting systolic blood pressure after 12 months

  3. Change from baseline in standing systolic blood and diastolic pressure after 12 months

  4. Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline

  5. Blood pressure less than 140/90 mmHg

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
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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