Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
- Registration Number
- NCT01541189
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description valsartan 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.
- Primary Outcome Measures
Name Time Method Change from baseline and week 2 in blood pressure at week 10 Baseline, 2 week and 10 weeks
- Secondary Outcome Measures
Name Time Method 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 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 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 during 10 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Beijing, Beijing, China