Comparison of Two Treatment Strategies in Hypertensive Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171444

Enrollment

4445

Registered

2005-09-15

Start date

2004-06-30

Completion date

2005-05-31

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension,, valsartan+hydrochlorothiazide

Brief summary

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.

Interventions

BEHAVIORALMedical education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026