Nctid:
NCT00000102
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000312", "term"=>"Adrenal Hyperplasia, Congenital"}, {"id"=>"D047808", "term"=>"Adrenogenital Syndrome"}, {"id"=>"D000308", "term"=>"Adrenocortical Hyperfunction"}, {"id"=>"D006965", "term"=>"Hyperplasia"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D012734", "term"=>"Disorders of Sex Development"}, {"id"=>"D014564", "term"=>"Urogenital Abnormalities"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000013", "term"=>"Congenital Abnormalities"}, {"id"=>"D030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D043202", "term"=>"Steroid Metabolism, Inborn Errors"}, {"id"=>"D008661", "term"=>"Metabolism, Inborn Errors"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000307", "term"=>"Adrenal Gland Diseases"}, {"id"=>"D004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D006058", "term"=>"Gonadal Disorders"}], "browseLeaves"=>[{"id"=>"M10016", "name"=>"Hyperplasia", "asFound"=>"Hyperplasia", "relevance"=>"HIGH"}, {"id"=>"M3664", "name"=>"Adrenal Hyperplasia, Congenital", "asFound"=>"Congenital Adrenal Hyperplasia", "relevance"=>"HIGH"}, {"id"=>"M25853", "name"=>"Adrenogenital Syndrome", "asFound"=>"Congenital Adrenal Hyperplasia", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3660", "name"=>"Adrenocortical Hyperfunction", "asFound"=>"Adrenal Hyperplasia", "relevance"=>"HIGH"}, {"id"=>"M15545", "name"=>"Disorders of Sex Development", "relevance"=>"LOW"}, {"id"=>"M12", "name"=>"Congenital Abnormalities", "relevance"=>"LOW"}, {"id"=>"M17314", "name"=>"Urogenital Abnormalities", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M11641", "name"=>"Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M25119", "name"=>"Steroid Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M3659", "name"=>"Adrenal Gland Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M9163", "name"=>"Gonadal Disorders", "relevance"=>"LOW"}, {"id"=>"T27", "name"=>"21-hydroxylase Deficiency", "asFound"=>"Congenital Adrenal Hyperplasia", "relevance"=>"HIGH"}, {"id"=>"T1457", "name"=>"Congenital Adrenal Hyperplasia", "asFound"=>"Congenital Adrenal Hyperplasia", "relevance"=>"HIGH"}, {"id"=>"T2879", "name"=>"Hyperadrenalism", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D009543", "term"=>"Nifedipine"}], "ancestors"=>[{"id"=>"D002121", "term"=>"Calcium Channel Blockers"}, {"id"=>"D049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014665", "term"=>"Vasodilator Agents"}, {"id"=>"D015149", "term"=>"Tocolytic Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}], "browseLeaves"=>[{"id"=>"M7992", "name"=>"Epinephrine", "relevance"=>"LOW"}, {"id"=>"M30371", "name"=>"Racepinephrine", "relevance"=>"LOW"}, {"id"=>"M211043", "name"=>"Epinephryl borate", "relevance"=>"LOW"}, {"id"=>"M5381", "name"=>"Calcium", "relevance"=>"LOW"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M12483", "name"=>"Nifedipine", "asFound"=>"Improved", "relevance"=>"HIGH"}, {"id"=>"M5384", "name"=>"Calcium Channel Blockers", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}, {"id"=>"M17869", "name"=>"Tocolytic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-01", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Congenital Adrenal Hyperplasia"]}, "descriptionModule"=>{"briefSummary"=>"This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).", "detailedDescription"=>"This protocol is designed to assess both acute and chronic effects of the calcium channel antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels, as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid treatment in CAH."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"35 years", "minimumAge"=>"14 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* diagnosed with Congenital Adrenal Hyperplasia (CAH)\n* normal ECG during baseline evaluation\n\nExclusion Criteria:\n\n* history of liver disease, or elevated liver function tests\n* history of cardiovascular disease"}, "identificationModule"=>{"nctId"=>"NCT00000102", "briefTitle"=>"Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets", "organization"=>{"class"=>"NIH", "fullName"=>"National Center for Research Resources (NCRR)"}, "orgStudyIdInfo"=>{"id"=>"NCRR-M01RR01070-0506"}, "secondaryIdInfos"=>[{"id"=>"M01RR001070", "link"=>"https://reporter.nih.gov/quickSearch/M01RR001070", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nifedipine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Medical University of South Carolina", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Center for Research Resources (NCRR)", "class"=>"NIH"}}}}
