Status:
COMPLETED
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief Summary
This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.
Eligibility Criteria
Inclusion
- Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.
- At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and \< 110 mmHg.
Exclusion
- If a single reading for arterial hypertension in msSBP \> 180 mmHg or msDBP \> 110 mmHg at any visit after randomization.
- Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
- Known history of hypotensive symptoms or orthostatic hypotension.
- Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- A history of heart failure (NYHA II-IV).
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00396656
Start Date
December 1 2005
End Date
December 1 2007
Last Update
June 6 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigative Centers, Germany
2
Novartis Pharma Ag
Basel, Switzerland