Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 April 2022 |
Main ID: |
EUCTR2017-002840-34-AT |
Date of registration:
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22/05/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study
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Scientific title:
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An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat |
Date of first enrolment:
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03/08/2018 |
Target sample size:
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200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002840-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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Costa Rica
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France
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Germany
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India
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Italy
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Japan
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Korea, Republic of
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Netherlands
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Poland
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Portugal
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Russian Federation
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Spain
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Thailand
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Turkey
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United States
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Lindenstrasse, 8
6340
Baar
Switzerland |
Telephone:
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Email:
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clinicaltrials.endocrinology@recordati.com |
Affiliation:
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Recordati AG |
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Name:
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Clinical Trial Information Desk
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Address:
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Lindenstrasse, 8
6340
Baar
Switzerland |
Telephone:
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Email:
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clinicaltrials.endocrinology@recordati.com |
Affiliation:
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Recordati AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Currently participating in a Global Novartis-sponsored osilodrostat study 2. Currently benefiting from treatment with osilodrostat, as determined by the Investigator 3. Demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements 4. Willingness and ability to comply with scheduled visits and treatment plans 5. Written informed consent obtained prior to enrolling into the roll-over study Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria: 1. Permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study 2. Receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS 3. Pregnant or nursing women 4. Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping medication
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Hormonal diseases [C19]
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Cushing's syndrome MedDRA version: 20.0
Level: PT
Classification code 10011652
Term: Cushing's syndrome
System Organ Class: 10014698 - Endocrine disorders
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Intervention(s)
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Product Name: osilodrostat 1mg Product Code: LCI699 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: osilodrostat Current Sponsor code: LCI699 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-
Product Name: osilodrostat 5mg Product Code: LCI699 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: osilodrostat Current Sponsor code: LCI699 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: osilodrostat 10mg Product Code: LCI699 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: osilodrostat Current Sponsor code: LCI699 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Main Objective: To evaluate long-term safety data based on frequency and severity of AEs/SAEs
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Primary end point(s): Frequency and severity of AEs/SAEs
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Secondary Objective: To evaluate clinical benefit as assessed by the Investigator To evaluate long term safety data based on laboratory evaluations, vital signs , ECG and pituitary MRI
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Timepoint(s) of evaluation of this end point: Throughout the trial
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Secondary Outcome(s)
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Secondary end point(s): Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits Frequency, severity and summaries of relevant safety assessments, including : laboratory evaluations, vital signs (blood pressure and body weight), ECG and pituitary MRI.
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Timepoint(s) of evaluation of this end point: Throughout the trial
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Secondary ID(s)
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CLCI699C2X01B
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Source(s) of Monetary Support
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Recordati AG
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Ethics review
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Status: Approved
Approval date: 03/08/2018
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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