A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

This study has been completed.

First Received on October 14, 2005. Last Updated on November 22, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00241137

Purpose

The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives

Condition	Intervention	Phase
Hypertension	Drug: valsartan	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline diastolic blood pressure after 4 weeks

Secondary Outcome Measures:

Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks
Adverse events and serious adverse events at each study visit for 4 weeks

Enrollment:	3790
Study Start Date:	September 2003
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Male or female age between 18-80 years of age, inclusive
- Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP >= 95 and =< 109 mmHg for non treated patients.
- Previously treated patients should have a MSDBP =< 109 mmHg at visit 1 and a MSDBP >= 95 and =< 109 mmHg at visit 2.
- Written informed consent to participate in the study prior to any study procedures
- Ability to communicate and comply with all study requirements

Exclusion Criteria:

Severe hypertension (grade 3 of WHO classification; >= 110 mmHg diastolic and/or >= 180 mmHg systolic).
Malignant hypertension
Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
Known history of proteinuria (greater than 0.3 gram per day)
Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1.
Transient ischemic cerebral attack during the last 12 months prior to Visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241137

Locations

Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceutical

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00241137 History of Changes
Other Study ID Numbers:	CVAL489H2301
Study First Received:	October 14, 2005
Last Updated:	November 22, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Novartis:

hypertension
valsartan

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012