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Nifedipine gastrointestinal therapeutic system+ Candesartan cilexetil · 1 trial · 1 indication
Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events.
Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal.
| Arm | Type | Description |
|---|---|---|
| Nifedipine + Candesartan cilexetil | EXPERIMENTAL | Coadministration of single doses of nifedipine and candesartan tablets |
| Name | Type | Description |
|---|---|---|
| Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil | DRUG | Candesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours. |
Inclusion Criteria: * Healthy male volunteers * Age 30-55 years * BMI 18.0-29.9 kg/m² * Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Nifedipine gastrointestinal therapeutic system (GITS) plus candesartan cilexetil is a fixed combination of two small molecule cardiovascular agents developed by Bayer AG. The pairing combines nifedipine GITS, a calcium channel blocker, with candesartan cilexetil. It has been studied in a clinical pharmacology setting rather than for a specific disease indication.
Nifedipine GITS targets the calcium channel subunits CACNA1C, CACNA1S, CACNA1D, and CACNA1F, acting as a blocker. Candesartan cilexetil is an angiotensin II receptor blocker. Together the two components act on separate cardiovascular pathways, one limiting calcium influx and the other blocking angiotensin II signaling.
Bayer AG is the developer of the nifedipine GITS plus candesartan cilexetil combination. Bayer trades on the OTC market under the ticker BAYRY. The nifedipine GITS component is also known by the brand name Adalat LA and the code BAY a1040.
The combination is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational combination and is not described as approved for any indication. The completed study enrolled 12 healthy male volunteers in Germany.
Trial NCT03136666 was a single dose escalation study of nifedipine GITS and candesartan tablets given together under fasting conditions in healthy male subjects. It used an open label, non-randomized, sequential design, enrolled 12 participants aged 30 years and older in Germany, and has been completed.
Adalat LA is a brand name for the nifedipine GITS component alone, not for the full combination. The combination product also carries the code BAY a1040 for that nifedipine component. The combined therapy pairs nifedipine GITS with candesartan cilexetil as a separate active ingredient.