To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8 weeks in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive monotherapy.
Study design: it's a A prospective, open-label, multicenter, single-arm study. After a one- to two-week screening period, subjects receive Nifedipine GITS 60mg for 8 weeks. The primary objective is to evaluate the antihypertensive efficacy of 8-week Nifedipine GITS 60mg treatment in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive mono-therapy. The secondary objective is to evaluate the tolerability of Nifedipine GITS 60mg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
278
Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment
Unnamed facility
Fuzhou, Fujian, China
Unnamed facility
Tangshan, Hebei, China
Unnamed facility
Wudan, Hubei, China
Unnamed facility
Changsha, Hunan, China
Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg
Time frame: At week 8
Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8
Time frame: baseline and week 8
Percentage of subjects with a Mean Sitting Systolic Blood Pressure Lower than 140mmHg and MSDBP less than 90 mmHg (130 and 80 for diabetis patients) of Nifedipine GITs 60mg
Time frame: At week 2 and week 4
The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)
Time frame: At week 2 and week 4
The percentage of subjects achieving both a ≥10mmHg
Time frame: At week 8
Time to reach the MSSBP target (based on the BP measurements during office visits)
The MSSBP target means : 140 mmHg for others, 130 mmHg for diabetes
Time frame: up to week 8
Changes in the 24-h, daytime (from 06:00 to 22:00), and nighttime (from 22:00 to 06:00) average SBP and DBP assessed by ABPM from baseline at Week 8
Time frame: baseline and week 8
incidence of all treatment-emergent adverse events
Time frame: At week 8
incidence of drug-related treatment-emergent adverse events
Time frame: at week 8
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Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Xi’an, Shanxi, China
Unnamed facility
Hangzhou, Zhejiang, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
...and 4 more locations