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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Valsartan

Criteria

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