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

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.

Official Title
-----------------
A 8-week, Multi Center(10),Single Arm, Open-labeled Prospective Study of Valsartan 160 mg in 200 Mild to Moderate Chinese Hypertension Patients Forced Titrated From 2-week Therapy of Valsartan 80 mg.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Valsartan


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: valsartan<br>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. | Drug: Valsartan<br>* 80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline and week 2 in blood pressure at week 10 |  | Baseline, 2 week and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of of patients who achieve BP<140/90mmHg |  | Baseline and 10 weeks | 
| Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10 | Each subject will receive 24-hour ABPM at baseline and week 10. | Baseline and 10 weeks | 
| Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10 | Each subject will receive HBPM at baseline, week 2, week 6 and week 10 respectively.For baseline HBPM, it was performed in the evening before visit 2 and in the morning of visit 2(before intake of study drug). in terms of the following 3 times of HBPM, they are performed during 5 days before each visit. | Baseline and 10 weeks | 
| Number of patients with adverse events, serious adverse events |  | during 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, valsartan