Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
|ClinicalTrials.gov Identifier: NCT01541189|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Valsartan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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
- Change from baseline and week 2 in blood pressure at week 10 [ Time Frame: Baseline, 2 week and 10 weeks ]
- Percentage of of patients who achieve BP<140/90mmHg [ Time Frame: Baseline and 10 weeks ]
- Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10 [ Time Frame: Baseline and 10 weeks ]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 ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541189
|Novartis Investigative Site|
|Beijing, Beijing, China, 100044|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|