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A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

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Novartis

Status and phase

Completed
Phase 3

Conditions

HYPERTENSION

Treatments

Drug: valsartan + amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170976
CVAA489A2307E1

Details and patient eligibility

About

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

Enrollment

403 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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