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OpenTrials
Completed

NCT Number: NCT00171405

A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 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 Site, Deurne, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
  • absence of ongoing severe adverse events at Visit 10.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study

Secondary outcomes

  1. Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months

  2. Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months

  3. Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months

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

  5. Blood pressure less than 140/90 mmHg

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 4 Month Extension to 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
2005
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Nov 18, 2016

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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