Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease (LINC-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02697734
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : October 19, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.

Condition or disease Intervention/treatment Phase
Cushing's Disease Drug: osilodrostat Drug: osilodrostat Placebo Phase 3

Detailed Description:

The study LCI699C2302 (LINC-4) is a multi-center, randomized, double-blind study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease.

Enrolled patients were initially randomized to either osilodrostat or placebo, in a 2:1 ratio, for a 12-week double-blind period (Period 1). Randomization was stratified by history of pituitary radiation. After Week 12, all patients received open-label osilodrostat until the end of the Core phase at Week 48 (Period 2).

After Week 48, patients could join an optional 48 week extension period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: osilodrostat Group
Participants in this arm were randomized to receive the study drug, osilodrostat followed after Week 12 by open-label osilodrostat at the starting dose (with a second dose titration)
Drug: osilodrostat
In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.
Other Name: LCI699

Placebo Comparator: osilodrostat Placebo Group
Participants in this arm were randomized to receive osilodrostat placebo followed after Week 12 by open-label osilodrostat at the starting dose (with a dose titration)
Drug: osilodrostat Placebo
Matching Placebo in the form of filmcoated tablets for oral administration




Primary Outcome Measures :
  1. Percentage of Randomized Participants With a Complete Response [ Time Frame: at Week 12 ]

    A complete responder at week 12 is defined as a participant who had a mean urine free cortisol ≤ upper limit of normal (mUFC ≤ ULN) at Week 12.

    Participants who had a missing mUFC assessment at Week 12 were counted as non-responders for the primary endpoint.



Secondary Outcome Measures :
  1. Percentage of Participants With mUFC ≤ ULN at Week 36 [ Time Frame: At Week 36 ]
    The complete response rate in both arms combined at Week 36. A complete responder at Week 36 is defined as a participant who had mean urine free cortisol <= upper limit of normal (mUFC <= ULN) at Week 36. Participants with missing mUFC at Week 36 were counted as non-responders.

  2. Change From Baseline in mUFC [ Time Frame: Baseline, weeks 2,5,8,12,14,17,20,23,26,29,32,36,40,48,60,72,84,96 ]
    To assess the change in mean urinary free cortisol (mUFC) from baseline by treatment arm.

  3. Time-to-first Control of mUFC - Number (%) of Participants With mUFC <=ULN [ Time Frame: up to 12 weeks ]

    To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period.

    Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier.


  4. Time-to-first Control of mUFC - Median Time to First Controlled mUFC Response [ Time Frame: up to 12 weeks ]

    To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period.

    Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier.

    The median time-to-first control and corresponding two-sided 95% Confidence Interval were calculated using Kaplan-Meier methodology of Brookmeyer and Crowley (1982).


  5. Time-to-first Control of mUFC - % Event Probability Estimates [ Time Frame: up to 12 weeks ]

    To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period.

    Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier.

    % Event probability estimate is the estimated probability that a participant will have an event prior to the specified time point. % Event probability estimates are obtained from the Kaplan-Meier survival estimates for all treatment groups; Greenwood formula is used for Confidence Interval (CI) of Kaplan-Meier (KM) estimates.


  6. Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN - Number (%) of Participants [ Time Frame: up to 48 weeks ]
    To assess time-to-escape from the first collection of normal mUFC (≤ ULN) to the first mUFC > 1.3 x ULN on two consecutive visits on the highest tolerated dose of osilodrostat and not related to a dose interruption or dose reduction due to safety reasons. Escape will not be assessed for participants during the first 26 weeks.

  7. Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN - Median Time to Escape From Normal mUFC [ Time Frame: from week 26 to week 48 ]

    To assess time-to-escape from the first collection of normal mUFC (≤ ULN) to the first mUFC > 1.3 x ULN on two consecutive visits on the highest tolerated dose of osilodrostat and not related to a dose interruption or dose reduction due to safety reasons. Escape will not be assessed for participants during the first 26 weeks.

    The median time-to-escape and corresponding two-sided 95% Confidence Interval were calculated using Kaplan-Meier methodology of Brookmeyer and Crowley (1982).


  8. Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN - % Event Probability Estimates [ Time Frame: week 26 and week 36 ]

    Escape is defined as the first loss of control of urinary free cortisol (UFC) that meets all of the following criteria: 1. prior normalization of UFC has occurred (median urinary free cortisol (mUFC)≤ upper limit of normal (ULN)); 2. patient reached the highest tolerated dose of osilodrostat; 3. 2 consecutive mUFC (collected at scheduled visits) were above 1.3x ULN; 4. the loss of control of UFC is not related to a dose interruption or dose reduction due to safety reasons; 5. happened beyond Week 26 when the patients have a chance to be treated with doses as high as 30 mg bid.

    • Event probability estimate is the estimated probability that a participant will have an event prior to the specified time point.
    • Event probability estimates are obtained from the Kaplan-Meier survival estimates for all treatment groups; Greenwood formula is used for CI of KM estimates.

  9. Change From Baseline in Bone Mineral Density (BMD) by Dual-energy X-ray Absorptiometry (DXA) Scan at the Femoral Neck, Hip and Spinal Cord - QC Corrected [ Time Frame: Baseline, week 48 ]
    The change from baseline in bone mineral density at the femoral neck, hip and spinal cord at Week 48 by treatment arm - QC corrected. An increase in bone mineral density is indicative of an improvement.

  10. Change From Baseline in Bone Mineral Density (BMD) T-score by Dual-energy X-ray Absorptiometry (DXA) Scan at the Femoral Neck, Hip and Spinal Cord - QC Corrected [ Time Frame: Baseline, week 48 ]
    The change from baseline in bone mineral density at the femoral neck, hip and spinal cord at Week 48 by treatment arm - QC corrected. An increase in bone mineral density is indicative of an improvement. T-score is the number of standard deviations above or below the mean for a healthy 30-year-old adult of the same sex and ethnicity as the patient. The WHO criteria are: Normal is a T-score of -1.0 or higher"

  11. Patients With a Complete Response (mUFC ≤ ULN) or a Partial Response (mUFC Decrease ≥ 50% From Baseline and >ULN) at Week 12, 36 and 48 [ Time Frame: baseline, week 12, 36 and 48 ]
    Overall response rate defined as percentage of complete responders (mUFC ≤ ULN) plus partial responders (≥ 50% reduction in mUFC from baseline and >ULN) at week 12, 36, 48 by treatment arms for all patients.

  12. Change in Fasting Plasma Glucose [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in fasting plasma glucose at Week 12, Week 36, and Week 48 by treatment arm

  13. Change in Hemoglobin A1C [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Hemoglobin A1C (%) at Week 12, Week 36, and Week 48 by treatment arm

  14. Change in Cholesterol [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Cholesterol (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm

  15. Change in LDL Cholesterol [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in LDL Cholesterol (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm

  16. Change in HDL Cholesterol [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in HDL Cholesterol (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm

  17. Change in Triglyceride [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Triglyceride (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm

  18. Change in Standing Systolic Blood Pressure [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Standing Systolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm

  19. Change in Supine Systolic Blood Pressure [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Supine Systolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm

  20. Change in Standing Diastolic Blood Pressure [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Standing Diastolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm

  21. Change in Supine Diastolic Blood Pressure [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Supine Diastolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm

  22. Change in Weight [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Weight (kg) at Week 12, Week 36, and Week 48 by treatment arm

  23. Change in Waist Circumference [ Time Frame: Baseline, weeks 12, 36, and 48 ]
    Change from baseline in Waist Circumference (cm) at Week 12, Week 36, and Week 48 by treatment arm

  24. Change From Baseline to Week 12, Week 36, and Week 48 in Clinical Signs of Cushing's Disease [ Time Frame: baseline, Week 12, Week 36 and Week 48 ]
    Change from baseline to Week 12, Week 36, and Week 48 in each of the following clinical signs of Cushing's disease, captured by: a semi-quantitative Likert scale for facial rubor, striae, supraclavicular fat pad, dorsal fat pad, proximal muscle wasting (atrophy), central (abdominal) obesity, and ecchymoses (bruises) by randomized treatment arm. The number/proportion of participants with an improvement or no change compared to baseline are reported

  25. Change From Baseline in Standardized Health Related Quality of Life Score, Using Cushing Disease-specific Quality of Life Patient Reported Outcome (PRO) Assessment [ Time Frame: Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48. ]

    The CushingQoL is a valid and reliable disease-specific QoL questionnaire which assesses health-related quality of life (HRQoL) in patients with Cushing's syndrome and has been validated in patients with Cushing's disease. The CushingQoL consists of questions reflecting dimensions of HRQoL related to physical aspects (e.g. 'I bruise easily'), psychological aspects (e.g. 'I am more irritable, I have sudden mood swings and angry outbursts'), and social aspects (e.g. 'I have had to give up my social or leisure activities due to my illness').

    The questionnaire consists of 12 items measured on a five point Likert-type scale assessing how often or how much each item has been related to the patient's Cushing's disease in the previous week. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Increases from baseline are indicative of an improvement.


  26. Change From Baseline in Standardized Psychosocial Issues Score, Using Cushing Disease-specific Quality of Life Patient Reported Outcome (PRO) Assessment [ Time Frame: Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48. ]

    The CushingQoL is a valid and reliable disease-specific QoL questionnaire which assesses health-related quality of life (HRQoL) in patients with Cushing's syndrome and has been validated in patients with Cushing's disease. The CushingQoL consists of questions reflecting dimensions of HRQoL related to physical aspects (e.g. 'I bruise easily'), psychological aspects (e.g. 'I am more irritable, I have sudden mood swings and angry outbursts'), and social aspects (e.g. 'I have had to give up my social or leisure activities due to my illness').

    The questionnaire consists of 12 items measured on a five point Likert-type scale assessing how often or how much each item has been related to the patient's Cushing's disease in the previous week. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Increases from baseline are indicative of an improvement.


  27. Change From Baseline in Standardized Physical Problems Score, Using Cushing Disease-specific Quality of Life Patient Reported Outcome (PRO) Assessment [ Time Frame: Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48. ]

    The CushingQoL is a valid and reliable disease-specific QoL questionnaire which assesses health-related quality of life (HRQoL) in patients with Cushing's syndrome and has been validated in patients with Cushing's disease. The CushingQoL consists of questions reflecting dimensions of HRQoL related to physical aspects (e.g. 'I bruise easily'), psychological aspects (e.g. 'I am more irritable, I have sudden mood swings and angry outbursts'), and social aspects (e.g. 'I have had to give up my social or leisure activities due to my illness').

    The questionnaire consists of 12 items measured on a five point Likert-type scale assessing how often or how much each item has been related to the patient's Cushing's disease in the previous week. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Increases from baseline are indicative of an improvement.


  28. Change From Baseline in EQ-5D-5L Utility Index [ Time Frame: Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48. ]

    EQ-5D-5L Utility Index:

    The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.


  29. Change From Baseline in EQ-5D VAS [ Time Frame: Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48. ]
    The EQ-5D-5L also includes a 20 cm vertical, VAS (visual analogue scale) with a scale of 0-100, with endpoints labeled 100='the best health you can imagine' and 0='the worst health you can imagine'. A single index value is analyzed for the EQ-5D-5L VAS score. An increase from baseline in the EQ-ED-5L VAS is indicative of an improvement.

  30. Change From Baseline in Beck Depression Inventory-II - Total Score Derived [ Time Frame: Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48. ]
    The Beck Depression Inventory II (BDI-II) is a patient reported instrument that consists of 21 items designed to assess the intensity of depression in clinical and normal patients in the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. A global score ranges from 0 to 63 and is calculated with a higher score representing a greater level of depression. The following scoring guidelines for interpretation of BDI-II have been suggested (Smarr, 2011): Minimal range =0-13, Mild depression =14-19, Moderate depression =20-28 and Severe depression = 29-63. A reduction from baseline in BDI-II is indicative of an improvement.

  31. Change From Baseline in Serum Cortisol [ Time Frame: Baseline, Week 12, Week 36, Week 48 ]
    Change from baseline in serum cortisol

  32. Change From Baseline in Late Night Saliva Cortisol [ Time Frame: Baseline, Week 12, Week 36, Week 48 ]
    Change from baseline in late night saliva cortisol (nmol/L)

  33. Change From Baseline in Morning Saliva Cortisol [ Time Frame: Baseline, Week 12, Week 36, Week 48 ]
    Change from baseline in morning saliva cortisol (nmol/L)

  34. Change From Baseline in Hair Cortisol Levels [ Time Frame: Baseline, Week 26, Week 48 ]
    Change from baseline in hair cortisol levels

  35. Plasma Osilodrostat Concentrations (ng/mL) [ Time Frame: pre-dose and 1-2hrs post dose at weeks 1, 2, 5, 8, 12, 14, 20, 26 ]
    Plasma osilodrostat concentrations (ng/mL)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  • Confirmed Cushing's Disease (CD) that is persistent or recurrent as evidenced by all of the following criteria being met (i.e., a, b and c):

    1. mUFC > 1.3 x ULN (Mean of three 24-hour urine samples collected preferably on 3 consecutive days, during screening after washout of prior medical therapy for CD (if applicable), confirmed by the central laboratory and available before Day 1), with ≥2 of the individual UFC values being > 1.3 x ULN.
    2. Morning plasma Adrenocorticotropic hormone (ACTH) above Lower Limit of Normal
    3. Confirmation (based on medical history) of pituitary source of excess

      ACTH as defined by any one or more of the following three criteria:

    i. Histopathologic confirmation of an ACTH-staining adenoma in patients who have had prior pituitary surgery. OR ii. Magnetic resonance imaging (MRI) confirmation of pituitary adenoma > 6 mm OR iii. Bilateral inferior petrosal sinus sampling (BIPSS) with either corticotropic-releasing hormone (CRH) or desmopressin (DDAVP) stimulation for patients with a tumor ≤ 6mm. The criteria for a confirmatory BIPSS test are any of the following: Pre-dose central to peripheral ACTH gradient > 2; Post-dose central to peripheral ACTH gradient > 3 after either CRH or DDAVP stimulation

  • Patients that received glucocorticoid replacement therapy must have discontinued such therapy for at least seven days or 5 half-lives prior to screening, whichever is longer.
  • Patients with de novo CD can be included only if they are not considered candidates for surgery (e.g., poor surgical candidates due to co-morbidities, inoperable tumors, patients who refuse to have surgical treatment, or surgical treatment is not available).

Key exclusion criteria:

  • Patients with pseudo-Cushing's syndrome. This may be diagnosed by a normal late night salivary cortisol value collected during the screening period and after washout of prior CD medication.
  • Patients with risk factors for QT corrected (QTc) prolongation or Torsade de Pointes, including:

patients with a baseline QT corrected (Fridericia QT formula) (QTcF) > 450 ms for males and QTcF > 460 ms for females; personal or family history of long QT syndrome; concomitant medications known to prolong the QT interval; patients with hypokalemia, hypocalcaemia, or hypomagnesaemia, if not corrected before pre-dose Day 1.

  • Patients likely to require adrenalectomy, pituitary surgery, or radiation therapy during the placebo-controlled period (Weeks 1-12) for the treatment of severe hypercortisolism or pituitary tumor growth causing compression of the optic chiasm.
  • Patients with compression of the optic chiasm due to a macroadenoma or patients at high risk of compression of the optic chiasm (tumor within 2 mm of optic chiasm).
  • Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1, AIP).
  • Patients with Cushing's syndrome due to ectopic ACTH secretion or ACTH independent (adrenal) Cushing's syndrome. Pregnant or nursing (lactating) women. 8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after completion of dosing. Highly effective contraception methods include: A. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. B. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study drug. In case of bilateral oophorectomy, documentation is required (e.g. operative report, pelvic ultrasound or other reliable imaging method). C. Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.

D. Combination of any two of the following (a+b or a+c, or b+c):

  1. Use of oral*, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
  2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
  3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. *In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study drug. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697734


Locations
Layout table for location information
United States, Colorado
University of Colorado Endocrinology Clinical Trials Unit
Aurora, Colorado, United States, 80045
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oregon
Oregon Health and Science University SC LCI699C2301
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Brazil
Novartis Investigative Site
Fortaleza, CE, Brazil, 60430-275
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-590
Novartis Investigative Site
Sao Paulo, SP, Brazil, 04039 004
Novartis Investigative Site
Sao Paulo, SP, Brazil, 05403 000
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2W 1T8
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1H 5N4
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site
Beijing, China, 100034
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Guang Zhou, China, 510080
Costa Rica
Novartis Investigative Site
San Pedro, San Jose, Costa Rica, Costa Rica, 1406 1200
Greece
Novartis Investigative Site
Athens, Greece, 106 76
Poland
Novartis Investigative Site
Warszawa, Mazowieckie, Poland, 04-305
Novartis Investigative Site
Krakow, Poland, 31-501
Novartis Investigative Site
Warszawa, Poland, 03 242
Portugal
Novartis Investigative Site
Porto, Portugal, 4200-319
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117036
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29009
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site
Madrid, Spain, 28009
Switzerland
Novartis Investigative Site
Luzern, Switzerland, 6000
Thailand
Novartis Investigative Site
Bangkok, THA, Thailand, 10330
Novartis Investigative Site
Bangkok, Thailand, 10700
Turkey
Novartis Investigative Site
Istanbul, Turkey, 34890
Novartis Investigative Site
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] December 20, 2019
Statistical Analysis Plan  [PDF] December 1, 2020

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02697734    
Other Study ID Numbers: CLCI699C2302
First Posted: March 3, 2016    Key Record Dates
Results First Posted: October 19, 2021
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

URL: https://www.clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's disease
LCI699
osilodrostat
Pituitary Gland
Adrenocorticotropic
Hormone
ACTH
UFC
Additional relevant MeSH terms:
Layout table for MeSH terms
ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site