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OpenTrials
Completed

NCT Number: NCT00170989

Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Patients with mild to moderate hypertension

Exclusion criteria

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

valsartan plus hydrochlorothiazide

Drug

Primary outcomes

  1. Change from baseline in diastolic blood pressure from baseline after 8 weeks

Secondary outcomes

  1. Change from baseline in systolic blood pressure from baseline after 8 weeks

  2. Change from baseline in standing systolic and diastolic blood pressure after 8 weeks

  3. Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks

  4. Diastolic blood pressure less than 90 mmHg after 8 weeks

  5. Adverse events and serious adverse events at 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 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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