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Comparison of Two Treatment Strategies in Hypertensive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171444
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171444


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171444     History of Changes
Other Study ID Numbers: CVAH631DFR06
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
Last Verified: September 2005

Keywords provided by Novartis:
hypertension,
valsartan+hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action