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Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

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Novartis

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: Hydrochlorothiazide
Drug: Amlodipine 10 mg
Drug: Valsartan 320 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171054
CVAL489A2418

Details and patient eligibility

About

The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.

Enrollment

125 patients

Sex

Female

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Postmenopausal women
  • Mild to moderate hypertension
  • Statin therapy or LDL≤ 4.1 mmol/L

Exclusion criteria

  • Severe hypertension
  • LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication
  • Certain hormonal therapy
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Diabetes
  • Raynaud's disease or any other significant peripheral vascular disease
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

125 participants in 2 patient groups

Valsartan 320 mg
Experimental group
Treatment:
Drug: Valsartan 320 mg
Drug: Hydrochlorothiazide
Amlodipine 10 mg
Experimental group
Treatment:
Drug: Amlodipine 10 mg
Drug: Hydrochlorothiazide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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