Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nifedipine GITS (Adalat LA, BAYA1040)
Nifedipine GITS · 2 trials · 2 indications
An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.
| Arm | Type | Description |
|---|---|---|
| Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | EXPERIMENTAL | Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg). |
| Nifedipine GITS 20 mg | EXPERIMENTAL | Subjects received 20 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule |
| Nifedipine GITS 30 mg | EXPERIMENTAL | Subjects received 30 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule |
| Nifedipine GITS 60 mg | EXPERIMENTAL | Subjects received 60 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule |
| Candesartan cilexetil 4 mg | EXPERIMENTAL | Subjects received 4 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets |
| Candesartan cilexetil 8 mg | EXPERIMENTAL | Subjects received 8 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets |
| Candesartan cilexetil 16 mg | EXPERIMENTAL | Subjects received 16 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets |
| Candesartan cilexetil 32 mg | EXPERIMENTAL | Subjects received 32 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets |
| Nifedipine/candesartan 20/4 mg | EXPERIMENTAL | Subjects received the combination of 20 mg of nifedipine GITS/4 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 20/8 mg | EXPERIMENTAL | Subjects received the combination of 20 mg of nifedipine GITS/8 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 20/16 mg | EXPERIMENTAL | Subjects received the combination of 20 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 30/8 mg | EXPERIMENTAL | Subjects received the combination of 30 mg of nifedipine GITS/8 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 30/16 mg | EXPERIMENTAL | Subjects received the combination of 30 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 30/32 mg | EXPERIMENTAL | Subjects received the combination of 30 mg of nifedipine GITS/32 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 60/16 mg | EXPERIMENTAL | Subjects received the combination of 60 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Nifedipine/candesartan 60/32 mg | EXPERIMENTAL | Subjects received the combination of 60 mg of nifedipine GITS/32 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets |
| Placebo | PLACEBO_COMPARATOR | Subjects received placebo (3 tablets and 1 capsule) once daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) | DRUG | Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily |
| Candesartan cilexetil (Atacand), 4 mg | DRUG | 4 mg of candesartan as capsule |
| Candesartan cilexetil (Atacand), 8 mg | DRUG | 8 mg candesartan as capsule |
| Nifedipine GITS (Adalat, BAYA1040), 20 mg | DRUG | 20 mg nifedipine as tablet |
| Nifedipine GITS (Adalat, BAYA1040), 30 mg | DRUG | 30 mg nifedipine as tablet |
| Nifedipine GITS (Adalat, BAYA1040), 60 mg | DRUG | 60 mg nifedipine as tablet |
| Placebo | DRUG | 3 different placebo tablets corresponding nifedipine doses and 1 placebo capsule corresponding to candesartan doses |
| Candesartan cilexetil (Atacand), 16 mg | DRUG | 16 mg of candesartan as capsule |
| Candesartan cilexetil (Atacand), 32 mg | DRUG | 32 mg of candesartan as capsule |
Inclusion Criteria: * Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of \>/= 160 mmHg and \< 200 mmHg, as measured by a calibrated electronic BP measuring de...