Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541189

CVAL489ACN14

Details and patient eligibility

About

To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
• All treatment-naive patients need to have 140mmHg≤MSSBP<180mmHg and 90mmHg≤MSDBP< 110mmHg at visit 1
• For patients on mono antihypertensive therapy, MSSBP/MSDBP should <160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and <180mmHg AND MSDBP≥90 mmHg and <110mmHg

Exclusion criteria

• Severe hypertension
• Malignant hypertension
• Secondary hypertension
• Renal dysfunction(serum creatinine > 2.0mg(176.8μmol/L)at visit 1)
• Hepatic disease
• History of hypertensive encephalopathy or cerebrovascular accident within 6 months
• History of myocardial infarction, coronary revascularization within 6 months
• Type 1 diabetes mellitus
• patietns with HbA1c >8% at visit 1
• Women in pregnancy and lactation
• Potentially fertile female patients not using effective contraceptive methods
• Be allergy to study drug.

Other protocol defined inclusion/exlusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

valsartan

Experimental group

Description:

After 1-week screening period, all of the eligible patients receive valsartan 80mg/day for 2 weeks, then the dosage will be titrated to 160mg/day for further 8 weeks therapy for all of the subjects.

Treatment:

Drug: Valsartan