Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-04 @ 9:33 PM
Study NCT ID:
NCT03776058
Status:
COMPLETED
Last Update Posted:
2018-12-14
First Post:
2018-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2000-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2000-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': '4 weeks'}, {'measure': 'Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Serum Calcium', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in 1,25 dihydroxy Vitamin D3', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in Serum Phosphorus', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in N-telopeptide (NTx)', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in Urine Osmolality', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in Calcium/Creatinine Ratio', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in Phosphorus/Creatinine Ratio', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Percent Change from Baseline in N-telopeptide/Creatinine Ratio', 'timeFrame': 'Baseline and week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'The primary objectives were to assess the safety and tolerability of twice daily (BID) doses of 65 mg cinacalcet administered orally to adults with primary HPT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women ≥ 18 years old before beginning of screening\n* Use, in the opinion of the principal investigator, effective contraceptive measures throughout the study\n* Negative serum pregnancy test within 15 days before day 0\n* Plasma iPTH concentration \\> 45 pg/mL on at least 2 occasions (during the screening phase) at least 7 days apart\n* Serum calcium concentration ≥ 11 mg/dL on 2 occasions (during the screening phase) at least 7 days apart\n* Acceptable renal function, with an estimated creatinine clearance \\> 50 mL/min as determined by the Cockroft and Gault equation\n* Acceptable hepatic function, defined as serum aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin ≤ 2 times the upper limit of normal (central laboratory's range)\n* Laboratory test results within the central laboratory's normal range for hematology, coagulation, urinalysis, and clinical chemistry parameters not mentioned specifically in other inclusion/exclusion criteria\n* Chest x-ray within the past 12 months, with no evidence of an active infectious, inflammatory, or malignant process\n* Informed consent for participation in the study\n\nExclusion Criteria:\n\n* Any unstable medical condition requiring hospitalization within 30 days before day 0, or otherwise unstable condition in the judgment of the investigator\n* Awaiting or scheduled for parathyroidectomy within 2 months after study day 0\n* Pregnant or nursing\n* Received, within 21 days before day 0, therapy with systemic glucocorticoids (\\> 5 mg/day prednisone or equivalent), lithium, tricyclic antidepressants (with the exception of amitriptyline and nortriptyline), thioridazine, haloperidol, flecainide, drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (ie, thiazide or loop diuretics), or calcitonin\n* Dose changes in bisphosphonates, thyroid replacement therapy, selective estrogen receptor modulators (SERMs), or changes in daily doses of estrogen (greater than 0.75 mg) within 90 days before day 0\n* Subjects who discontinued estrogen or SERM therapy must have been off treatment for at least 90 days before day 0.\n* Alcohol or illicit drug abuse within 12 months before day 0 based on self-report\n* Myocardial infarction within 6 months before day 0\n* Ventricular rhythm disturbance requiring current treatment\n* Seizure within 12 months before day 0\n* History (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer\n* Evidence (within 5 years) of treatment for and/or active sarcoidosis, tuberculosis, or diseases other than primary HPT known to cause hypercalcemia\n* History of familial hypocalciuric hypercalcemia (FHH)\n* Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0\n* Gastrointestinal disorder that may be associated with impaired absorption of orally administered medications\n* Inability to swallow tablets similar in size to an aspirin tablet\n* Known sensitivity to products administered during the study\n* Previous participation as a subject in this study (ie, withdrawn early) or a prior study involving AMG 073 administration\n* Enrolled in, or not yet completed at least 28 days since ending other investigational device or drug trial(s)\n* Psychiatric disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements\n* Any other condition that might reduce the chance of obtaining data (ie, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent"}, 'identificationModule': {'nctId': 'NCT03776058', 'briefTitle': 'Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Clinical Effects of Twice-daily Doses of an Oral Calcimimetic Agent (AMG 073) in Subjects With Primary Hyperparathyroidism (HPT)', 'orgStudyIdInfo': {'id': '00990160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cinacalcet', 'description': 'Participants received 65 mg cinacalcet orally twice a day for 4 weeks.', 'interventionNames': ['Drug: Cinacalcet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo to cinacalcet orally twice a day for 4 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cinacalcet', 'type': 'DRUG', 'otherNames': ['AMG 073', 'Sensipar®', 'Mimpara®'], 'description': 'Tablets for oral administration', 'armGroupLabels': ['Cinacalcet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets for oral administration', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}