Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine (Adalat GITS, BAY1040) | Drug | Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy after proctocolectomy)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou | Fujian | 350001 | China | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At week 2 and week 4 |
| The percentage of subjects with a MSDBP lower than 90 (80 for diabetis) | At week 2 and week 4 |
| The percentage of subjects achieving both a ≥10mmHg | 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 | 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 | baseline and week 8 |
| incidence of all treatment-emergent adverse events | At week 8 |
| incidence of drug-related treatment-emergent adverse events | at week 8 |
| Tangshan |
| Hebei |
| 063000 |
| China |
| Wudan | Hubei | 430022 | China |
| Changsha | Hunan | 410008 | China |
| Nanjing | Jiangsu | 210008 | China |
| Xi’an | Shanxi | 710061 | China |
| Hangzhou | Zhejiang | 310006 | China |
| Beijing | 100028 | China |
| Beijing | 100037 | China |
| Beijing | China |
| Shandong | China |
| Shanghai | 200025 | China |
| Tangshang | China |
| Tianjin | 300052 | China |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided