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

NCT00241137 | Completed Phase 3

• 1 other identifier: CVAL489H2301
• Study Type: interventional
• Target: 3,790
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

hypertension; valsartan

Outcome Measures

Primary Outcomes (1)

• Change from baseline diastolic blood pressure after 4 weeks

Secondary Outcomes (3)

• 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

Interventions

valsartan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Unknown Facility

Investigative Centers, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceutical

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: September 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: November 23, 2011

Record last verified: 2006-06

Locations

DE (1)