Safety and Efficacy of Valsartan Versus Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharma Ag, Principal Investigator, Affiliation: Novartis
Summary
This study will evaluate the effect of valsartan on small vessel blood flow in patients with
mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide
Clinical Details
Official title: A Randomized, Open-Label, Multicenter, Cross-Over Trial to Evaluate the Efficacy of a 20 Week Treatment of Valsartan 320 mg Versus Atenolol 100 mg in Combination With Hydrochlorothiazide on Microcirculation in Hypertensive Patients
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Microcirculation following intradermal application of acetylcholine in patients with mild to moderate essential hypertension at baseline, 20 weeks.
Secondary outcome: Microcirculation following intradermal application of acetylcholine in the presence of L-NMMA in patients with mild to moderate essential hypertension at baseline, 20 weeks.Vascular responses to individual dosages of provocation test substances such as acetylcholine with or without L-NMMA, L-NMMA alone and Sodium nitroprusside. Microcirculation following intradermal application of a sodium chloride solution in patients with mild to moderate essential hypertension at baseline, 20 weeks Arterial stiffness markers and pulse wave reflection Safety and tolerability.
Eligibility
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- If a single reading for arterial hypertension in MSSBP > 180 mm Hg or MSDBP of 110 mm
Hg 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).
Locations and Contacts
Investigative Centers, Germany
Novartis Pharma Ag, Basel, Switzerland
Additional Information
Starting date: December 2005
Last updated: July 6, 2007
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