Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: February 23, 2012
Last updated: November 12, 2013
Last verified: November 2013
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline and week 2 in blood pressure at week 10 [ Time Frame: Baseline, 2 week and 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of of patients who achieve BP<140/90mmHg [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]Each subject will receive 24-hour ABPM at baseline and week 10.
- Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]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.
- Number of patients with adverse events, serious adverse events [ Time Frame: during 10 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks
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