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Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

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Novartis

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: amlodipine
Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00351130
CVAH631B2406E1

Details and patient eligibility

About

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

Enrollment

79 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

Exclusion criteria

  • Premature discontinuation in the core study or failure to comply with the core study protocol
  • Any patient that the investigator decides should not participate in the extension

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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