Hypertension
Conditions
Keywords
BAYA1040_Nifedipine, Nifedipine, Essential hypertension, Japanese Patients, Phase III, 13176
Brief summary
This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040\_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040\_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040\_Nifedipine 40 mg once daily treatment.
Interventions
BAYA1040\_Nifedipine 40mg twice daily (BID)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 20 years or older * Japanese male or female * Outpatient with essential hypertension * Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug
Exclusion criteria
* Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more * Patients with secondary hypertension or hypertensive emergency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy changes measured by sitting diastolic blood pressure (DBP) | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy changes measured by sitting systolic blood pressure (SBP) | Up to 8 weeks |
| Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines | Up to 8 weeks |
| Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP | Up to 8 weeks |
Countries
Japan
Outcome results
None listed