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

Tracking Information

First Received Date ^ICMJE

October 14, 2005

Last Updated Date

November 13, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline diastolic blood pressure after 4 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00241137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: valsartan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3236

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00241137

Responsible Party

Study ID Numbers ^ICMJE

CVAL489H2301

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceutical

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP