A Phase 3 interventional study of Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) and Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) in Hypertension, sponsored by Bayer. Withdrawn at 8 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-22.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone.
Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone.
Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks.
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Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)
Drug: Candesartan Cilexetil · Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo · Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan placebo, Placebo combination A, Combination nifedipine / candesartan 30/16 mg)
Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) · Drug: Candesartan matching placebo
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan placebo, Placebo combination B, Combination nifedipine / candesartan 60/16 mg)
Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) · Drug: Candesartan matching placebo · Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 30/16 mg, tablet, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16 mg, tablet, orally, once daily
Candesartan Cilexetil, 16 mg, capsule, orally, once daily
Candesartan matching placebo, capsule, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily
Change in mean seated systolic blood pressure (MSSBP).
Time frame: From baseline to treatment week 8
Change in mean seated diastolic blood pressure (MSDBP).
Time frame: From baseline to treatment week 8
Blood pressure Response Rate
Response rate is defined as the percentage of subjects achieving a systolic blood pressure (SBP) response (MSSBP of \< 140 mmHg or a reduction of MSSBP of \> 20 mm Hg from baseline value), or a diastolic blood pressure (DBP) response (i.e. MSDBP of \< 90 mmHg or a reduction of MSDBP of \> 10 mm Hg from baseline value) after 8 weeks treatment.
Time frame: Treatment week 8
Blood pressure Control Rate
Control rate is the percentage of subjects that reach the predetermined blood pressure(BP) target \< 140/90 mmHg. In addition, the percentage of subjects that reach the predetermined BP target \< 140/90 mmHg for subjects without diabetes or chronic renal disorder(baseline estimated glomerular filtration rate(GFR) \< 60 mL/min); \<130/80 mmHg for subjects with diabetes or chronic renal disorder will be provided as well.
Time frame: Treatment week 8
Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.
Time frame: Treatment week 8
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: Treatment week 8
This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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