Hypertension
Conditions
Keywords
BAYA1040, Nifedipine, Essential hypertension, Japanese Patients, Phase III, combination study, 14024
Brief summary
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040\_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040\_Nifedipine 40 mg once daily and other antihypertensives.
Interventions
Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study
Exclusion criteria
* Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg 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 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy changes measured by sitting systolic blood pressure (SBP) | Up to 52 weeks | — |
| Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines | Up to 52 weeks | — |
| Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP | Up to 52 weeks | — |
| Safety variables | Up to 30 days after the last dose of study drug | Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated. |
Countries
Japan
Outcome results
None listed