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OpenTrials
Completed

NCT Number: NCT00338936

Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

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

Inclusion criteria

  • Patients who successfully complete the core study (Protocol 1303)
  • Outpatients

Exclusion criteria

  • Presence of crucial protocol violation in Protocol 1303
  • Patients who experienced any adverse events considered serious and drug related in Protocol 1303.

Treatment and study plan

Valsartan + Hydrochlorothiazide

Drug

Primary outcomes

  1. Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.

Secondary outcomes

  1. Change from baseline in average sitting diastolic blood pressure after 52 weeks

  2. Change from baseline in average sitting systolic blood pressure after 52 weeks

  3. Change from baseline in average standing diastolic blood pressure after 52 weeks

  4. Change from baseline in average standing systolic blood pressure after 52 weeks

  5. Laboratory abnormalities after 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 52-week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 20, 2006
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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