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

NCT ID: NCT01541189

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-01-31

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

valsartan

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.

Group Type: EXPERIMENTAL

Valsartan

Intervention Type: DRUG

80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks

Interventions

Valsartan

80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CVAL489ACN14

Identifier Type: -

Identifier Source: org_study_id