18 and older, any sex, with Cushings Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN Collected or Imputed at Week 35Primary· Baseline up to week 35
Participants who attained mUFC ≤ 1.0 x ULN (upper limit of normal) with pasireotide alone or in combination with cabergoline. The 24h-UFC concentration results from three samples, collected during the screening period, were averaged to obtain the Baseline urinary free cortisol level. mean 24h-UFC was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit. Imputation: subjects who completed the end of treatment visit at Week 35, but had missing evaluation of mean urinary free cortisol (mUFC). The last available mUFC assessment at or after
Group
Value
95% CI
All Patients
50.0
37.6 – 62.4
Mean Urinary Free Cortisol (mUFC) at Scheduled VisitsSecondary· Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
Mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
Baseline
Group
Value
95% CI
All Patients
501.6
± 488.66
Core Week 2 n-8
Group
Value
95% CI
All Patients
217.0
± 100.69
Core Week 4 n=59
Group
Value
95% CI
All Patients
242.1
± 203.47
Core Week 8 n=58
Group
Value
95% CI
All Patients
230.0
± 195.21
Core Week 13 n=51
Group
Value
95% CI
All Patients
231.0
± 240.98
Core Week 17 n=57
Group
Value
95% CI
All Patients
310.3
± 429.64
Core Week 22 n=50
Group
Value
95% CI
All Patients
214.0
± 202.80
Core Week 26 n=54
Group
Value
95% CI
All Patients
211.6
± 173.58
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULNSecondary· Baseline up to week 235
Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
Baseline
Group
Value
95% CI
All Patients
4.4
0.9 – 12.4
Core Week 17 n=57
Group
Value
95% CI
All Patients
28.1
17.0 – 41.5
Core Week 35 n=45
Group
Value
95% CI
All Patients
48.9
33.7 – 64.2
Ext Week 43 n=22
Group
Value
95% CI
All Patients
63.6
40.7 – 82.8
Ext Week 67 n=17
Group
Value
95% CI
All Patients
47.1
23.0 – 72.2
Ext Week 91 n=18
Group
Value
95% CI
All Patients
61.1
35.7 – 82.7
Ext Week 115 n=13
Group
Value
95% CI
All Patients
76.9
46.2 – 95.0
Ext Week 139 n=9
Group
Value
95% CI
All Patients
77.8
40.0 – 97.2
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFCSecondary· Baseline up to week 235
Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
Baseline
Group
Value
95% CI
All Patients
4.4
0.9 – 12.4
Core Week 17 n=57
Group
Value
95% CI
All Patients
54.4
40.7 – 67.6
Core Week 35 n=45
Group
Value
95% CI
All Patients
68.9
53.4 – 81.8
Ext Week 43 n=22
Group
Value
95% CI
All Patients
86.4
65.1 – 97.1
Ext Week 67 n=17
Group
Value
95% CI
All Patients
76.5
50.1 – 93.2
Ext Week 91 n=18
Group
Value
95% CI
All Patients
83.3
58.6 – 96.4
Ext Week 115 n=13
Group
Value
95% CI
All Patients
92.3
64.0 – 99.8
Ext Week 139 n=9
Group
Value
95% CI
All Patients
77.8
40.0 – 97.2
Duration (Weeks) of Controlled or Partially Controlled ResponseSecondary· from the date patient's first normalization (mUFC ≤ 1.0xULN) or at least 50% reduction from baseline up to the date when the patient's mUFC > 1.0 x ULN
Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC ≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC \> 1.0 x ULN and the reduction from baseline falls to less than 50% from the first time
Core n=36
Group
Value
95% CI
All Patients
13.1
9.3 – 22.4
Extension n=20
Group
Value
95% CI
All Patients
22.0
8.1 – 70.1
Plasma Adrenocorticotropic Hormone (ACTH)Secondary· Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
A pre-dose blood draw for plasma ACTH sampling was taken at visits. Samples were analyzed by a central laboratory.
Baseline
Group
Value
95% CI
All Patients
16.3
± 16.3
Core Week 2 n-62
Group
Value
95% CI
All Patients
12.4
± 9.91
Core Week 4 n=63
Group
Value
95% CI
All Patients
14.2
± 12.50
Core Week 8 n=61
Group
Value
95% CI
All Patients
13.3
± 11.90
Core Week 13 n=53
Group
Value
95% CI
All Patients
11.9
± 10.98
Core Week 17 n=58
Group
Value
95% CI
All Patients
12.3
± 9.03
Core Week 22 n=49
Group
Value
95% CI
All Patients
13.7
± 13.82
Core Week 26 n=55
Group
Value
95% CI
All Patients
12.4
± 12.09
Serum Cortisol LevelsSecondary· Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
A pre-dose blood draw for an 8 am fasting serum cortisol measurement were taken at visits. Samples were analyzed by a central laboratory.
Baseline
Group
Value
95% CI
All Patients
738.6
± 332.53
Core Week 2 n-62
Group
Value
95% CI
All Patients
626.1
± 281.57
Core Week 4 n=64
Group
Value
95% CI
All Patients
663.6
± 292.38
Core Week 8 n=61
Group
Value
95% CI
All Patients
649.0
± 297.11
Core Week 13 n=53
Group
Value
95% CI
All Patients
628.8
± 269.43
Core Week 17 n=58
Group
Value
95% CI
All Patients
683.0
± 282.28
Core Week 22 n=49
Group
Value
95% CI
All Patients
625.4
± 216.29
Core Week 26 n=55
Group
Value
95% CI
All Patients
632.7
± 278.75
Sitting Systolic Blood Pressure at Week 35Secondary· Baseline and week 35
The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures
Baseline
Group
Value
95% CI
All Patients
125.9
± 14.3
Week 35 n=41
Group
Value
95% CI
All Patients
119.5
± 18.6
Sitting Diastolic Blood Pressure at Week 35Secondary· Baseline and week 35
The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures
Baseline
Group
Value
95% CI
All Patients
81.8
± 9.12
Week 35 n=41
Group
Value
95% CI
All Patients
77.2
± 12.42
Body Weight at Week 35Secondary· Baseline and week 35
Weight was was one of the measures of clinical symptoms of CD
Baseline
Group
Value
95% CI
All Patients
82.2
± 19.1
Week 35 n=41
Group
Value
95% CI
All Patients
75.6
± 20.4
Body Mass Index at Week 35Secondary· Baseline and week 35
Body mass index was one of the measurements of clinical symptoms of CD. Body mass index=weight in kg divided by the square of the body height (in meters)
Baseline
Group
Value
95% CI
All Patients
31.3
± 6.6
Week 35 n=41
Group
Value
95% CI
All Patients
28.4
± 6.8
Waist Circumference at Week 35Secondary· Baseline and week 35
Waist circumference was one of the measurements of clinical signs of CD
Baseline
Group
Value
95% CI
All Patients
104.1
± 19.1
Week 35 n=41
Group
Value
95% CI
All Patients
99.1
± 18.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
All Patients
Serious: 15/68 (22%)
Deaths: 3/68
Serious adverse events (33 terms)
Reaction
System
All Patients
Abdominal pain
Gastrointestinal disorders
—
Cholelithiasis
Hepatobiliary disorders
—
Anaemia
Blood and lymphatic system disorders
—
Coronary artery disease
Cardiac disorders
—
Glucocorticoid deficiency
Endocrine disorders
—
Intra-abdominal haematoma
Gastrointestinal disorders
—
Death
General disorders
—
Multiple organ dysfunction syndrome
General disorders
—
Bile duct stone
Hepatobiliary disorders
—
Cholecystitis
Hepatobiliary disorders
—
Abscess limb
Infections and infestations
—
Cellulitis
Infections and infestations
—
Varicella
Infections and infestations
—
Hip fracture
Injury, poisoning and procedural complications
—
Muscle rupture
Injury, poisoning and procedural complications
—
Radius fracture
Injury, poisoning and procedural complications
—
Wound
Injury, poisoning and procedural complications
—
Alanine aminotransferase increased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Gamma-glutamyltransferase increased
Investigations
—
Diabetes mellitus
Metabolism and nutrition disorders
—
Hypoglycaemia
Metabolism and nutrition disorders
—
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The main purpose of this prospective, multicenter, open-label phase II study, was to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing's disease.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 18 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01915303.