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Completed

NCT Number: NCT00273299

Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension

The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.

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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

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

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

Inclusion criteria

  • Diagnosed severe hypertension

Exclusion criteria

  • Inability to discontinue all prior antihypertensive medications
  • Heart failure of any kind
  • History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
  • Diabetes with poor glucose control
  • 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. Blood pressure less than 140/90 mmHg after 4 weeks

Secondary outcomes

  1. Blood pressure less than 140/90 mmHg after 6 weeks

  2. Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks

  3. Systolic blood pressure less than 140 mmHg after 4 and 6 weeks

  4. Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks

  5. Adverse events and serious adverse events at each study visit for 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 9, 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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