Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Atenolol (Drug); Hydrochlorothiazide (HCTZ)) (Drug); Valsartan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharma Ag, Principal Investigator, Affiliation: Novartis Pharmaceuticals
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.
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites
Secondary outcome: Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected SitesDifference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites Mean Post-treatment Microcirculation at NaCl Injected Sites Arterial Pressure Waveform Augmentation Index at the End of Treatment Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment
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 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).
Locations and Contacts
Investigative Centers, Germany
Novartis Pharma Ag, Basel, Switzerland
Additional Information
Starting date: December 2005
Last updated: May 5, 2011
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