Clinical trial

A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

NCT00170976

Name

CVAA489A2307E1

Description

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Trial arms

Trial start

2004-04-01

Estimated PCD

2005-06-01

Trial end

2005-06-01

Status

Completed

Phase

Early phase I

Treatment

valsartan + amlodipine

Size

403

Primary endpoint

Adverse events and serious adverse events at each study visit for 6 or 12 months

Eligibility criteria

Inclusion Criteria: * SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL * VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg Exclusion Criteria: * PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE Other protocol-defined exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 403, 'type': 'ACTUAL'}}

Updated at

2023-10-12

1 organization

1 product

1 indication

Organization

Novartis

Product

Valsartan + Amlodipine

Indication

Hypertension