This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM
Valsartan 160 mg OM (Two Valsartan 80mg tablets)
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Shijiazhuang, Hebei, China
Unnamed facility
Changsha, Hunan, China
Unnamed facility
Changsha, Hunan, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Shenyang, Liaoning, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Shanghai, China
...and 7 more locations
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
Time frame: Baseline and 12 weeks of treatment
Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)
Time frame: 8 and 12 weeks of treatment
Control rate (</=140/90 of office BP)
Time frame: 8 and 12 weeks of treatment
Change in pulse pressure (difference between SBP and DBP)
Time frame: 12 weeks of treatment
Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria
Time frame: Baseline and 12 weeks of treatment
Adverse Event reporting
Time frame: At the start, every 4 weeks during treatment and at the end of treatment
Vitals signs
Time frame: At the start, every 4 weeks during treatment and at the end of treatment
Laboratory tests
Time frame: At the start and at the end of treatment
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