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OpenTrials
Completed

NCT Number: NCT00171444

Comparison of Two Treatment Strategies in Hypertensive Patients

The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.

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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

Who can participate

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

Inclusion criteria

  • • Male or female patients >18 years of age
  • Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects,

Exclusion criteria

  • • Severe hypertension, secondary hypertension, type 1 diabetes mellitus
  • History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Medical education

Behavioral

Primary outcomes

  1. Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks

Secondary outcomes

  1. Change from baseline systolic blood pressure after 8 weeks

  2. Change from baseline diastolic blood pressure after 8 weeks

  3. Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg

  4. Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 8-week Comparison, in a General Practice Setting, Between Two Treatment Strategies With Valsartan and Valsartan/HCTZ Aiming at Normalizing de Novo Hypertensive Patients Who Are Not Adequately Controlled With Their Monotherapy or Biotherapy Treatment or Experiencing Unacceptable Side-effects, According to Their Baseline Blood Pressure

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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