A Phase 3 interventional study of Nifedipine (Adalat, BAYA1040) in Hypertension, sponsored by Bayer. Completed at 22 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-01-29.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040 CR 40mg BID
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: Week 52
Changes from baseline in diastolic blood pressure (DBP) while sitting
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Changes from baseline in systolic blood pressure (SBP) while sitting
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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