{"id":"nifedipine-gits","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Headache"},{"rate":"5-15","effect":"Peripheral edema"},{"rate":"5-10","effect":"Flushing"},{"rate":"3-7","effect":"Dizziness"},{"rate":"2-5","effect":"Palpitations"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Nifedipine blocks L-type calcium channels in the cell membrane, preventing calcium entry into vascular smooth muscle and cardiac cells. This reduces intracellular calcium concentration, leading to relaxation of vascular smooth muscle and decreased peripheral vascular resistance. The GITS (Gastrointestinal Therapeutic System) formulation provides sustained release over 24 hours, enabling once-daily dosing for improved patient compliance in hypertension management.","oneSentence":"Nifedipine GITS is a long-acting calcium channel blocker that reduces calcium influx into vascular smooth muscle cells, causing vasodilation and lowering blood pressure.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:57:17.779Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"},{"name":"Angina pectoris"}]},"trialDetails":[{"nctId":"NCT02940548","phase":"PHASE4","title":"Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness","status":"TERMINATED","sponsor":"Jing Liu","startDate":"2016-12","conditions":"Hypertension","enrollment":99},{"nctId":"NCT02499822","phase":"PHASE4","title":"REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial","status":"COMPLETED","sponsor":"Istituto Auxologico Italiano","startDate":"2015-10","conditions":"Hypertension, High Blood Pressure Variability","enrollment":168},{"nctId":"NCT03194633","phase":"","title":"Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2017-07-10","conditions":"Hypertension","enrollment":871},{"nctId":"NCT04438720","phase":"PHASE1","title":"Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects","status":"UNKNOWN","sponsor":"Cao Yu","startDate":"2020-06-25","conditions":"Therapeutic Equivalency","enrollment":60},{"nctId":"NCT02641821","phase":"PHASE4","title":"Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension","status":"UNKNOWN","sponsor":"Peking University First Hospital","startDate":"2015-10","conditions":"Hypertension","enrollment":700},{"nctId":"NCT01788358","phase":"PHASE3","title":"Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-02-14","conditions":"Hypertension","enrollment":508},{"nctId":"NCT02413515","phase":"PHASE4","title":"Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-03-26","conditions":"Hypertension","enrollment":278},{"nctId":"NCT02047019","phase":"PHASE3","title":"Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil","status":"WITHDRAWN","sponsor":"Bayer","startDate":"2017-12-01","conditions":"Hypertension","enrollment":""},{"nctId":"NCT03136666","phase":"PHASE1","title":"Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-04-19","conditions":"Clinical Pharmacology","enrollment":12},{"nctId":"NCT01303783","phase":"PHASE2","title":"Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-04","conditions":"Hypertension, Essential","enrollment":1381},{"nctId":"NCT01227603","phase":"PHASE1","title":"Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-11","conditions":"Hypertension, Essential","enrollment":49},{"nctId":"NCT01350609","phase":"PHASE1","title":"Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-04","conditions":"Hypertension, Essential","enrollment":49},{"nctId":"NCT00672113","phase":"PHASE4","title":"Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension","status":"COMPLETED","sponsor":"Bayer","startDate":"2003-12","conditions":"Hypertension","enrollment":43},{"nctId":"NCT00750113","phase":"PHASE4","title":"Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-10","conditions":"Hypertension","enrollment":405},{"nctId":"NCT00993109","phase":"PHASE4","title":"Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-02","conditions":"Hypertension","enrollment":360},{"nctId":"NCT01030081","phase":"PHASE4","title":"Amlodipine Prevents Morning Blood Pressure Surge Study","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2009-10","conditions":"Hypertension","enrollment":510},{"nctId":"NCT01348880","phase":"PHASE1","title":"Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-05","conditions":"Erectile Dysfunction","enrollment":42},{"nctId":"NCT01071122","phase":"PHASE4","title":"FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-01","conditions":"Hypertension","enrollment":365},{"nctId":"NCT01167153","phase":"PHASE4","title":"Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients","status":"COMPLETED","sponsor":"Novartis","startDate":"2010-05","conditions":"Hypertension","enrollment":564},{"nctId":"NCT01021501","phase":"PHASE4","title":"The Pharmacokinetics of Nifedipine Controlled Release Tablets in Hypertensive Patients on Hemodialysis","status":"UNKNOWN","sponsor":"Guangzhou First People's Hospital","startDate":"2009-12","conditions":"Hypertension on Chronic Maintenance Hemodialysis","enrollment":20},{"nctId":"NCT00884442","phase":"PHASE1","title":"Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions","status":"COMPLETED","sponsor":"SocraTec R&D GmbH","startDate":"2009-04","conditions":"Bioavailability, Therapeutical Indication Not Studied","enrollment":28},{"nctId":"NCT00325936","phase":"PHASE4","title":"The Effects of Cilnidipine on Metabolic Syndrome Improvement","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2005-07","conditions":"Hypertension, Metabolic Syndrome X","enrollment":186},{"nctId":"NCT00173667","phase":"PHASE4","title":"A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"","conditions":"Hypertension","enrollment":60}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"ENDOMETRITIS"},{"count":2,"reaction":"FOETAL DEATH"},{"count":2,"reaction":"FOETAL GROWTH RESTRICTION"},{"count":2,"reaction":"HYPERTENSION"},{"count":2,"reaction":"MATERNAL EXPOSURE DURING PREGNANCY"},{"count":2,"reaction":"MUSCULAR WEAKNESS"},{"count":2,"reaction":"OFF LABEL USE"},{"count":2,"reaction":"PRE-ECLAMPSIA"},{"count":1,"reaction":"APHASIA"},{"count":1,"reaction":"ARTERIOSCLEROSIS"}],"_approvalHistory":[],"publicationCount":250,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Adalat"],"phase":"marketed","status":"active","brandName":"Nifedipine GITS","genericName":"Nifedipine GITS","companyName":"Peking University First Hospital","companyId":"peking-university-first-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nifedipine GITS is a long-acting calcium channel blocker that reduces calcium influx into vascular smooth muscle cells, causing vasodilation and lowering blood pressure. Used for Hypertension, Angina pectoris.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}