Approval Probability
TA Base Rate
Adjusted LOA
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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...
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Nifedipine GITS is a small molecule calcium channel blocker developed by Bayer AG for hypertension, including essential hypertension. GITS stands for gastrointestinal therapeutic system, a delivery design that releases the drug gradually. It is studied both as a stand-alone treatment and in a fixed dose combination with candesartan cilexetil.
Nifedipine GITS is used to treat hypertension, including essential hypertension, which is high blood pressure without an identifiable secondary cause. Clinical study NCT01303783 evaluated it in patients with essential hypertension, and NCT01788358 studied a fixed dose combination of Nifedipine GITS and candesartan cilexetil in moderate to severe essential hypertension.
Nifedipine GITS targets calcium channel subunits CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It acts as a blocker at these channels, which reduces calcium entry into vascular smooth muscle cells and lowers blood pressure. This mechanism underlies its use in hypertension.
Nifedipine GITS is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the sponsor behind the clinical program studying the drug in hypertension, including the fixed dose combination with candesartan cilexetil.
Nifedipine GITS is in Phase 3 development for hypertension. The Phase 3 study NCT01788358 has completed, and an earlier Phase 2 study, NCT01303783, also completed. It is an investigational asset in Bayer's cardiovascular pipeline rather than a newly approved product.
Two completed trials cover Nifedipine GITS. NCT01788358 was a Phase 3 open-label long-term safety and efficacy study of Nifedipine GITS plus candesartan cilexetil in moderate to severe essential hypertension, enrolling 508 subjects. NCT01303783 was a Phase 2 study comparing the combination with monotherapy in essential hypertension, enrolling 1,381 patients.
Yes. Nifedipine GITS is also known as Adalat LA and by the code BAYA1040. Related names include the Nifedipine GITS and candesartan cilexetil fixed dose combination, coded BAY98-7106. These names refer to the same Bayer nifedipine program, so searches for any of them point to the same asset.