Hypertension
Conditions
Keywords
hypertension, valsartan
Brief summary
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
Interventions
DRUGValsartan
80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline and week 2 in blood pressure at week 10 | Baseline, 2 week and 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed