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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Valsartan + Amlodipine besilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446524

CVAA489A1302

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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403 participants in 2 patient groups

Valsartan + Amlodipine 80/5 mg

Experimental group

Description:

Valsartan 80 mg or Amlodipine 5 mg ---\> Valsartan + Amlodipine 80 / 5 mg

Treatment:

Drug: Valsartan + Amlodipine besilate

Valsartan + Amlodipine 80/5 mg + Diuretic

Experimental group

Description:

Valsartan + Amlodipine 80 / 5 mg + Diuretic

Treatment:

Drug: Valsartan + Amlodipine besilate