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Completed

NCT Number: NCT00277472

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

This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.

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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

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female 18 years of age and older
  • Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg

Exclusion criteria

  • - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
  • Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
  • History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Valsartan/hydrochlorothiazide

Drug

160/12.5 mg taken once daily orally

Other names: Co-Diovan, Diovan HCT

HCTZ

Drug

25 mg taken once daily orally

Other names: hydrochlorothiazice, water pill

Primary outcomes

  1. Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks

  2. Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks

Secondary outcomes

  1. Change from baseline in systolic blood pressure after 2 weeks and 4 weeks

  2. Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks

  3. Change in systolic blood pressure at 20 weeks compared to 4 weeks

  4. Change in diastolic blood pressure at 20 weeks compared to 4 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy

Important dates

Study start
2005
Primary completion
2005
First posted
Jan 16, 2006
Registry last updated
Jun 7, 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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