Safety and Efficacy of Valsartan Versus Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00396656

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Valsartan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Atenolol Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Microcirculation following intradermal application of acetylcholine in patients with mild to moderate essential hypertension at baseline, 20 weeks.

Secondary Outcome Measures:

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.

Enrollment:	30
Study Start Date:	December 2005
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396656

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharma Ag
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharma Ag

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAH631BDE06
Study First Received:	November 6, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00396656 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Hypertension
valsartan
atenolol
hydrochlorothiazide

microcirculation
arterial compliance
pulse wave analysis

Additional relevant MeSH terms:

Neurotransmitter Agents
Sympatholytics
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sodium Chloride Symporter Inhibitors
Diuretics
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions

Membrane Transport Modulators
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Atenolol
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010