Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Valsartan + Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00338936

CVAH631B1303E1

Details and patient eligibility

About

This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

Enrollment: 362 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who successfully complete the core study (Protocol 1303)
• Outpatients

Exclusion criteria

• Presence of crucial protocol violation in Protocol 1303
• Patients who experienced any adverse events considered serious and drug related in Protocol 1303.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)