Comparison of Two Treatment Strategies in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171444
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: September 2005
  Purpose

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
Hypertension
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)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171444

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov 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:
hypertension,
valsartan+hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014