Long term study of Valsartan and Amlodipine in patients with essential hypertension (extension from Study CVAA489A1301)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220359

Enrollment

400

Registered

2007-03-14

Start date

2007-03-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

investigational material(s) Generic name etc : VAA489 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria - Participation in Study CVAA489A1301 - Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 trial was well controlled - Male or female outpatients Exclusion criteria - Presence of major protocol violation in Study CVAA489A1301 - Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301 Other protocol-defined inclusion/exclusion criteria may apply

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Safety assessed by serious and non-serious adverse events Secondary Outcomes: -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)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026