Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Valsartan

Criteria

Inclusion Criteria:

• Patients who successfully complete the core study (Study CVAA489A1301.

• Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP < 90 mmHg and MSSBP < 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was < 100 mmHg and MSSBP was < 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.

• Male or female outpatients.

• Patients who have written informed consent to participate in this study.

Exclusion Criteria:

• Presence of major protocol violation in Study CVAA489A1301.

• Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.

• Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.

• Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.

• Patients who have gout or gouty arthritis.

• Patients hypersensitive to diuretics (except for potassium sparing diuretics).

Other protocol-defined inclusion/exclusion criteria may apply