78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100

  
11 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2018-001989-42-SI
(EUCTR)
05/05/202205/05/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy
2EUCTR2018-001989-42-DE
(EUCTR)
02/05/202207/05/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy
3NCT04786873
(ClinicalTrials.gov)
November 16, 20213/3/2021A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it isMulticenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD)Growth Hormone DeficiencyDrug: Macimorelin;Diagnostic Test: Arginine;Diagnostic Test: ClonidineAEterna ZentarisNovo Nordisk A/SRecruiting2 Years17 YearsAll100Phase 3United States;Georgia;Germany;Italy;Poland;Romania;Serbia;Slovenia
4EUCTR2018-001989-42-PL
(EUCTR)
04/08/202129/06/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy
5EUCTR2018-001989-42-IT
(EUCTR)
03/08/202130/08/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects
MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
Product Code: [-]
INN or Proposed INN: CLONIDINA CLORIDRATO
Other descriptive name: Clonidine hydrochloride
Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: [AEZS-130]
INN or Proposed INN: macimorelina
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene
Product Name: Arginine Hydrochloride
Product Code: [NDC0009-0436-01]
INN or Proposed INN: ARGININA CLORIDRATO
Other descriptive name: ARGININE HYDROCHLORIDE
AETERNA ZENTARIS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy
6JPRN-UMIN000027260
2017/02/0607/05/2017Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loadingAnalysis of Airway Inflammatory state alteration after intravenous L-Arginine loading - Alteration of Airway Inflammatory state after intravenous L-Arginine loading(AILA) Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons.Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutesOsaka City University Graduate School of MedicineNULL2years-old15years-oldMale and Female15Not selectedJapan
7NCT00448747
(ClinicalTrials.gov)
June 200716/3/2007Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly Ardana (ARD)-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and EfficacyDiagnosis of Adult Growth Hormone Deficiency (AGDH)Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRHAEterna ZentarisNULLCompleted18 YearsN/AAll101Phase 3United States
8NCT00720902
(ClinicalTrials.gov)
February 200716/6/2008Adult Growth Hormone Deficiency and Cardiovascular RiskAssessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary AdenomasGrowth Hormone DeficiencyProcedure: Blood draws;Drug: Growth hormone releasing hormone (GHRH) and arginine;Procedure: Carotid ultrasound;Procedure: MRI;Procedure: Endothelial cell biopsyColumbia UniversityNULLTerminated19 Years65 YearsBoth8N/AUnited States
9NCT00468624
(ClinicalTrials.gov)
December 20042/5/2007Effect of Pegvisomant on GH/IGF-I Relationship in GHDA Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD)Severe Adult Growth Hormone DeficiencyDrug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limbChristie Hospital NHS Foundation TrustNULLTerminated18 Years70 YearsBothN/AUnited Kingdom
10NCT00134420
(ClinicalTrials.gov)
February 200122/8/2005Growth Hormone and Chromosome 18q- and Abnormal GrowthGrowth Hormone Trial for Children With 18q- and Abnormal GrowthLoss of Chromosome 18q;Growth Hormone DeficiencyDrug: Nutropin AQ;Procedure: Arginine and Clonidine Stimulation Testing;Procedure: Growth Factors Laboratory Testing;Procedure: Neuropsychological TestingThe University of Texas Health Science Center at San AntonioSouth Texas Veterans Health Care System;Genentech, Inc.CompletedN/A18 YearsBoth20Phase 3United States
11EUCTR2010-018781-23-NL
(EUCTR)
17/02/2010Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation TestsDiagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests To investigate if there is a correlation between the peak GH concentrations after ingestion of gelatin protein and the peak GH concentrations after the two standard tests (GHST) in order to discriminate growth hormone deficiency (GHD) and non-GHD. To investigate the differences in coefficient of variation between the different tests (arginine, clonidine, protein). To investigate the frequency of side effects in the different tests (arginine, clonidine, protein).
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Product Name: Gelatin
Product Code: 3
Product Name: Arginin
Product Code: 1
Trade Name: Clonidine HCl CF 0,150 mg, tabletten
Product Name: Clonidine
Product Code: 2
INN or Proposed INN: Clonidin
Other descriptive name: CLONIDINE HYDROCHLORIDE
Top Institute Food and NutritionNULLNAFemale: yes
Male: yes
Netherlands