Comparison of Two Treatment Strategies in Hypertensive Patients

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: September 2005

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.

Condition Intervention Phase
Behavioral: Medical education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change from baseline systolic blood pressure after 8 weeks
  • Change from baseline diastolic blood pressure after 8 weeks
  • Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg
  • Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg

Enrollment: 4445
Study Start Date: June 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00171444

Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novatis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Identifier: NCT00171444     History of Changes
Other Study ID Numbers: CVAH631DFR06
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses processed this record on April 17, 2014