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

Condition(s) targeted: Hypertension

Intervention: Valsartan + Amlodipine besilate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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.

Official title: A 54-week Extension to the Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAA489 in Patients With Essential Hypertension (Extension From A1301 Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety assessed by serious and non-serious adverse events

Secondary outcome:

Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure

Laboratory tests

Vital signs

Electrocardiogram (ECG)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Novartis Investigative Site, Fukuoka, Japan

Starting date: February 2007
Last updated: May 6, 2012