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Completed

NCT Number: NCT00280540

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 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 4

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

  • Male or female age 18 or older
  • Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)

Exclusion criteria

  • Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
  • History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
  • History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Valsartan/hydrochlorothiazide

Drug

Primary outcomes

  1. Change from baseline systolic blood pressure after 4 weeks

  2. Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary outcomes

  1. Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period

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

  3. Change from baseline diastolic blood pressure after 6 weeks

  4. Change from baseline in blood and urine markers after 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 6-week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension

Important dates

Study start
2005
Primary completion
2006
First posted
Jan 23, 2006
Registry last updated
Nov 9, 2010

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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