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An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. (SEASCAPE)

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ClinicalTrials.gov Identifier: NCT01582061
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cushing's Disease
Intervention Drug: Pasireotide sub-cutaneous
Enrollment 104
Recruitment Details  
Pre-assignment Details After a 21-day screening period, patients who met the inclusion/exclusion criteria received pasireotide subcutaneous twice a day (BID)
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg
Hide Arm/Group Description Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Period Title: Overall Study
Started 49 55
Completed 21 19
Not Completed 28 36
Reason Not Completed
Lack of Efficacy             3             23
Adverse Event             12             8
Withdrawal by Subject             10             4
Abnormal laboratory value(s)             1             0
Death             0             1
condition no longer requires study drug             1             0
Lost to Follow-up             1             0
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg Total
Hide Arm/Group Description Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day Total of all reporting groups
Overall Number of Baseline Participants 49 55 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 55 participants 104 participants
45.5  (13.14) 39.9  (12.55) 42.5  (13.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 55 participants 104 participants
Female
37
  75.5%
47
  85.5%
84
  80.8%
Male
12
  24.5%
8
  14.5%
20
  19.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 55 participants 104 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
  12.2%
15
  27.3%
21
  20.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.1%
2
   3.6%
5
   4.8%
White
39
  79.6%
36
  65.5%
75
  72.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.0%
2
   3.6%
3
   2.9%
1.Primary Outcome
Title Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
Hide Description Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
Time Frame Baseline up to approximately 256 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Three additional arms were created to display subset of subjects with specific criteria.
Arm/Group Title 600 µg Bid - All Grades 600 μg - Grades 3/4 900 μg - All Grades 900 μg - Grades 3/4 All Patients - All Grades All Patients - Grades 3/4
Hide Arm/Group Description:
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Adverse event grades 3 and 4. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Overall Number of Participants Analyzed 49 49 55 55 104 104
Measure Type: Number
Unit of Measure: percentage of participants
Any primary system organ class Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
53.1 53.1 29.1 27.3 40.4 39.4
Metabolism and nutrition disorders Number Analyzed 49 participants 26 participants 55 participants 55 participants 104 participants 104 participants
26.5 26.5 12.7 10.9 19.2 18.3
Gastrointestinal disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
18.4 18.4 7.3 7.3 12.5 12.5
Investigations Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
8.2 8.2 3.6 3.6 5.8 5.8
Hepatobiliary disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
2.0 2.0 5.5 5.5 3.8 3.8
Endocrine disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
6.1 6.1 0 0 2.9 2.9
Gen disorders,admin site conditions Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
4.1 4.1 0 0 1.9 1.9
Ear and labyrinth disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
2.0 2.0 0 0 1.0 1.0
Infections and infestations Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
2.0 2.0 0 0 1.0 1.0
Musculoskeletal and connective tissue disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
2.0 2.0 0 0 1.0 1.0
Neoplasms benign, malignant and unspecified Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
2.0 2.0 0 0 1.0 1.0
Nervous system disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
2.0 2.0 0 0 1.0 1.0
Psychiatric disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
0 0 1.8 1.8 1.0 1.0
Respiratory, thoracic, mediastinal disorders Number Analyzed 49 participants 49 participants 55 participants 55 participants 104 participants 104 participants
0 0 1.8 0 1.0 0
2.Secondary Outcome
Title Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
Hide Description The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12–week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory’s own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 27 participants 39 participants 66 participants
77.8
(57.74 to 91.38)
38.5
(23.36 to 55.38)
54.5
(41.81 to 66.86)
Week 24 Number Analyzed 22 participants 24 participants 46 participants
68.2
(45.13 to 86.14)
29.2
(12.62 to 51.09)
47.8
(32.89 to 63.05)
Week 48 Number Analyzed 10 participants 11 participants 21 participants
70.0
(34.75 to 93.33)
18.2
(2.28 to 51.78)
42.9
(21.82 to 65.98)
Week 24 (LOCF) Number Analyzed 37 participants 49 participants 86 participants
54.1
(36.92 to 70.51)
28.6
(16.59 to 43.26)
39.5
(29.15 to 50.66)
Week 48 (LOCF) Number Analyzed 37 participants 49 participants 86 participants
51.4
(34.40 to 68.08)
22.4
(11.78 to 36.62)
34.9
(24.92 to 45.92)
3.Secondary Outcome
Title Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline
Hide Description The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12–week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory’s own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 27 participants 39 participants 66 participants
74.1
(53.72 to 88.89)
48.7
(32.42 to 65.22)
59.1
(46.29 to 71.05)
Week 24 Number Analyzed 22 participants 24 participants 46 participants
68.2
(45.13 to 86.14)
33.3
(15.63 to 55.32)
50.00
(34.90 to 65.10)
Week 48 Number Analyzed 10 participants 11 participants 21 participants
60.0
(26.24 to 87.84)
54.5
(23.38 to 83.25)
57.1
(34.02 to 78.18)
Week 24 (LOCF) Number Analyzed 37 participants 49 participants 86 participants
56.8
(39.49 to 72.90)
38.8
(25.20 to 53.76)
46.5
(35.68 to 57.59)
Week 48 (LOCF) Number Analyzed 37 participants 49 participants 86 participants
51.4
(34.40 to 68.08)
42.9
(28.82 to 57.79)
46.5
(35.68 to 57.59)
4.Secondary Outcome
Title Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
Hide Description

A 12-item Cushing’s syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient

• Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with ‘Sometimes’ or ‘Somewhat’, X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, ‘change from baseline in WPAI-GH scores’ are not included.

Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who completed at least 9 questions on questionnaire were included for that visit.
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 47 54 101
Mean (Standard Deviation)
Unit of Measure: percent change in score
Week 12 Number Analyzed 33 participants 45 participants 78 participants
21.3  (47.03) 100.8  (252.25) 67.1  (197.09)
Week 24 Number Analyzed 23 participants 28 participants 51 participants
36.7  (59.25) 119.7  (321.61) 82.3  (243.19)
Week 48 Number Analyzed 15 participants 20 participants 35 participants
24.0  (37.76) 42.3  (60.75) 34.4  (52.29)
5.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Blood Pressure (BP)
Hide Description Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change of mmhg
Sitting systolic Week 12 Number Analyzed 35 participants 45 participants 80 participants
-6.8  (12.04) -1.4  (14.40) -3.8  (13.61)
Sitting systolic Week 24 Number Analyzed 24 participants 29 participants 53 participants
-7.4  (8.97) -5.7  (11.09) -6.5  (10.13)
Sitting systolic Week 48 Number Analyzed 16 participants 21 participants 37 participants
-5.1  (8.57) -4.7  (12.55) -4.9  (10.87)
Standing systolic Week 12 Number Analyzed 34 participants 44 participants 78 participants
-7.9  (12.49) -3.6  (15.38) -5.5  (14.27)
Standing systolic Week 24 Number Analyzed 23 participants 29 participants 52 participants
-10.9  (10.30) -6.7  (14.09) -8.6  (12.62)
Standing systolic Week 48 Number Analyzed 15 participants 21 participants 36 participants
-6.5  (9.45) -4.4  (13.86) -5.3  (12.10)
Sitting diastolic Week 12 Number Analyzed 35 participants 45 participants 80 participants
-4.6  (15.13) -0.2  (14.40) -2.1  (14.79)
Sitting diastolic Week 24 Number Analyzed 24 participants 29 participants 53 participants
-6.2  (7.29) -3.8  (15.83) -4.9  (12.65)
Sitting diastolic Week 48 Number Analyzed 16 participants 21 participants 37 participants
-3.3  (10.38) -4.3  (13.93) -3.8  (12.37)
Standing diastolic Week 12 Number Analyzed 34 participants 44 participants 78 participants
-5.5  (16.02) -1.9  (17.63) -3.5  (16.93)
Standing diastolic Week 24 Number Analyzed 23 participants 29 participants 52 participants
-7.6  (10.30) -5.3  (16.74) -6.3  (14.18)
Standing diastolic Week 48 Number Analyzed 15 participants 21 participants 36 participants
-2.1  (13.78) -4.4  (14.13) -3.4  (13.83)
6.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Pulse
Hide Description Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value – BL value)/ BL value)*100
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change in bpm
Sitting pulse Week 12 Number Analyzed 35 participants 45 participants 80 participants
2.3  (18.93) -7.5  (11.50) -3.2  (15.87)
Sitting pulse Week 24 Number Analyzed 24 participants 29 participants 53 participants
-1.8  (17.05) -2.6  (18.07) -2.2  (17.46)
Sitting pulse Week 48 Number Analyzed 16 participants 21 participants 37 participants
2.9  (16.39) 3.7  (15.46) 3.3  (15.65)
7.Secondary Outcome
Title Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
Hide Description degrees celius
Time Frame Baseline week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title 600 µg Bid - All Grades 900 μg - All Grades All Patients - All Grades
Hide Arm/Group Description:
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
All grades of adverse events. Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
All grades of adverse events for all patients who received 600 µg bid or 900 µg bid of pasireotide sub-cutaneous.
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change in celius
Week 12 Number Analyzed 33 participants 43 participants 76 participants
0.1  (1.26) -0.3  (1.06) -0.1  (1.17)
Week 24 Number Analyzed 21 participants 28 participants 49 participants
-0.1  (1.15) -0.1  (1.26) -0.1  (1.20)
Week 48 Number Analyzed 15 participants 20 participants 35 participants
0.03  (1.47) -0.1  (1.19) 0.1  (1.31)
8.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Body Mass Index (BMI)
Hide Description Percent change in patients reducing by at least one class level. Class levels: <25.0, 25.0 to <30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value – BL value)/ BL value)*100
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change in kg/m2
Week 12 Number Analyzed 35 participants 44 participants 79 participants
-4.2  (3.70) -4.8  (5.38) -4.5  (4.69)
Week 24 Number Analyzed 24 participants 29 participants 53 participants
-7.3  (5.46) -5.2  (6.51) -6.1  (6.10)
Week 48 Number Analyzed 16 participants 21 participants 37 participants
-8.0  (6.82) -6.3  (7.88) -7.0  (7.39)
9.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Weight
Hide Description Clinically relevant threshold (at any time point) was reduction of ≥ 5%
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change in kg
Week 12 Number Analyzed 35 participants 44 participants 79 participants
-4.2  (3.70) -4.8  (5.38) -4.5  (4.69)
Week 24 Number Analyzed 24 participants 29 participants 53 participants
-7.3  (5.46) -5.2  (6.51) -6.1  (6.10)
Week 48 Number Analyzed 16 participants 21 participants 37 participants
-8.0  (6.82) -6.3  (7.88) -7.0  (7.39)
10.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Muscle Strength
Hide Description Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change in scores
Week 12 Number Analyzed 13 participants 9 participants 22 participants
-34.6  (62.53) -53.7  (46.98) -42.4  (56.28)
Week 24 Number Analyzed 7 participants 7 participants 14 participants
-28.6  (48.80) -47.6  (50.40) -38.1  (48.67)
Week 48 Number Analyzed 5 participants 4 participants 9 participants
-30.0  (44.72) -75.0  (50.0) -50.0  (50.00)
11.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Waist Circumference
Hide Description Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 49 55 104
Mean (Standard Deviation)
Unit of Measure: percent change of centimeters
Week 12 Number Analyzed 35 participants 42 participants 77 participants
-2.0  (4.29) -2.9  (6.70) -2.5  (5.72)
Week 24 Number Analyzed 24 participants 28 participants 52 participants
-5.8  (6.28) -3.1  (5.48) -4.4  (5.96)
Week 48 Number Analyzed 16 participants 20 participants 36 participants
-5.1  (5.74) -4.1  (5.64) -4.6  (5.62)
12.Secondary Outcome
Title Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Hirsutism
Hide Description Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value – BL value)/ BL value)*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 37 47 84
Mean (Standard Deviation)
Unit of Measure: percent change in scores
Week 12 Number Analyzed 24 participants 31 participants 55 participants
-12.2  (24.57) -8.2  (35.30) -10.0  (30.88)
Week 24 Number Analyzed 16 participants 20 participants 36 participants
-21.2  (32.72) -16.2  (46.99) 18.4  (40.79)
Week 48 Number Analyzed 11 participants 15 participants 26 participants
-18.2  (30.12) 9.6  (143.83) -2.2  (110.20)
13.Secondary Outcome
Title Percent Change From Baseline in Growth Hormone (GH) Values
Hide Description Descriptive summary of the effect of pasireotide on GH.
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 48 55 103
Mean (Standard Deviation)
Unit of Measure: percent change of µg/L
Week 12 Number Analyzed 35 participants 45 participants 80 participants
-17.3  (109.89) -20.90  (156.60) -19.3  (137.33)
Week 24 Number Analyzed 22 participants 29 participants 51 participants
-22.2  (62.43) -26.2  (105.44) -24.4  (88.70)
Week 48 Number Analyzed 16 participants 20 participants 36 participants
23.1  (127.30) -1.0  (134.97) 9.7  (130.32)
14.Secondary Outcome
Title Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
Hide Description Descriptive summary of the effect of pasireotide on IGF-1
Time Frame Baseline, week 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with available data differed at visits
Arm/Group Title Pasireotide 600 μg Pasireotide 900 μg All Patients
Hide Arm/Group Description:
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Patients received pasireotide 600 μg or 900 μg BID
Overall Number of Participants Analyzed 48 53 101
Mean (Standard Deviation)
Unit of Measure: percent change of ng/ml
Week 12 Number Analyzed 34 participants 44 participants 78 participants
-53.4  (23.66) -57.8  (23.93) -55.9  (23.76)
Week 24 Number Analyzed 23 participants 29 participants 52 participants
-49.2  (26.56) -56.2  (26.55) -53.1  (26.53)
Week 48 Number Analyzed 16 participants 21 participants 37 participants
-41.8  (35.72) -52.1  (21.87) -47.6  (28.71)
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 256 weeks
Adverse Event Reporting Description Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator
 
Arm/Group Title 600 µg Bid 900 µg Bid All Patients
Hide Arm/Group Description 600 µg bid 900 µg bid All patients
All-Cause Mortality
600 µg Bid 900 µg Bid All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   1/55 (1.82%)   1/104 (0.96%) 
Show Serious Adverse Events Hide Serious Adverse Events
600 µg Bid 900 µg Bid All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/49 (26.53%)   17/55 (30.91%)   30/104 (28.85%) 
Blood and lymphatic system disorders       
Anaemia  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Cardiac disorders       
Atrial fibrillation  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Endocrine disorders       
Adrenal insufficiency  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Glucocorticoid deficiency  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Hyperprolactinaemia  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Pituitary-dependent Cushing's syndrome  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Gastrointestinal disorders       
Abdominal pain  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Diarrhoea  1  2/49 (4.08%)  1/55 (1.82%)  3/104 (2.88%) 
Gastrointestinal ulcer  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Pancreatitis  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Pancreatitis necrotising  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
General disorders       
Death  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Drug ineffective  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Hepatobiliary disorders       
Bile duct stone  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Cholangitis acute  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Cholecystitis acute  1  0/49 (0.00%)  3/55 (5.45%)  3/104 (2.88%) 
Cholelithiasis  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Hepatic lesion  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Infections and infestations       
Cellulitis  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Dengue fever  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Meningitis  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Pneumonia  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Investigations       
Blood cortisol increased  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Lipase abnormal  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Transaminases increased  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Weight increased  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  2/49 (4.08%)  1/55 (1.82%)  3/104 (2.88%) 
Hyperglycaemia  1  2/49 (4.08%)  0/55 (0.00%)  2/104 (1.92%) 
Hypoglycaemia  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Hypokalaemia  1  0/49 (0.00%)  2/55 (3.64%)  2/104 (1.92%) 
Type 2 diabetes mellitus  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pituitary tumour benign  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Nervous system disorders       
Headache  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Psychiatric disorders       
Suicide attempt  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/49 (2.04%)  0/55 (0.00%)  1/104 (0.96%) 
Pulmonary embolism  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Rhinorrhoea  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Vascular disorders       
Embolism venous  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
Venous thrombosis  1  0/49 (0.00%)  1/55 (1.82%)  1/104 (0.96%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
600 µg Bid 900 µg Bid All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/49 (100.00%)   54/55 (98.18%)   103/104 (99.04%) 
Cardiac disorders       
Bradycardia  1  2/49 (4.08%)  3/55 (5.45%)  5/104 (4.81%) 
Sinus bradycardia  1  4/49 (8.16%)  1/55 (1.82%)  5/104 (4.81%) 
Endocrine disorders       
Adrenal insufficiency  1  4/49 (8.16%)  1/55 (1.82%)  5/104 (4.81%) 
Hypothyroidism  1  3/49 (6.12%)  1/55 (1.82%)  4/104 (3.85%) 
Gastrointestinal disorders       
Abdominal discomfort  1  1/49 (2.04%)  3/55 (5.45%)  4/104 (3.85%) 
Abdominal pain  1  10/49 (20.41%)  9/55 (16.36%)  19/104 (18.27%) 
Abdominal pain upper  1  2/49 (4.08%)  6/55 (10.91%)  8/104 (7.69%) 
Constipation  1  1/49 (2.04%)  4/55 (7.27%)  5/104 (4.81%) 
Diarrhoea  1  28/49 (57.14%)  23/55 (41.82%)  51/104 (49.04%) 
Dry mouth  1  5/49 (10.20%)  3/55 (5.45%)  8/104 (7.69%) 
Dyspepsia  1  2/49 (4.08%)  4/55 (7.27%)  6/104 (5.77%) 
Faeces soft  1  4/49 (8.16%)  1/55 (1.82%)  5/104 (4.81%) 
Flatulence  1  6/49 (12.24%)  5/55 (9.09%)  11/104 (10.58%) 
Frequent bowel movements  1  3/49 (6.12%)  2/55 (3.64%)  5/104 (4.81%) 
Nausea  1  22/49 (44.90%)  26/55 (47.27%)  48/104 (46.15%) 
Vomiting  1  3/49 (6.12%)  7/55 (12.73%)  10/104 (9.62%) 
General disorders       
Asthenia  1  4/49 (8.16%)  7/55 (12.73%)  11/104 (10.58%) 
Fatigue  1  11/49 (22.45%)  12/55 (21.82%)  23/104 (22.12%) 
Injection site erythema  1  3/49 (6.12%)  2/55 (3.64%)  5/104 (4.81%) 
Oedema peripheral  1  9/49 (18.37%)  3/55 (5.45%)  12/104 (11.54%) 
Hepatobiliary disorders       
Cholelithiasis  1  8/49 (16.33%)  22/55 (40.00%)  30/104 (28.85%) 
Hepatic steatosis  1  1/49 (2.04%)  4/55 (7.27%)  5/104 (4.81%) 
Infections and infestations       
Gastroenteritis  1  3/49 (6.12%)  2/55 (3.64%)  5/104 (4.81%) 
Influenza  1  1/49 (2.04%)  3/55 (5.45%)  4/104 (3.85%) 
Nasopharyngitis  1  2/49 (4.08%)  7/55 (12.73%)  9/104 (8.65%) 
Upper respiratory tract infection  1  1/49 (2.04%)  6/55 (10.91%)  7/104 (6.73%) 
Urinary tract infection  1  0/49 (0.00%)  4/55 (7.27%)  4/104 (3.85%) 
Injury, poisoning and procedural complications       
Procedural nausea  1  3/49 (6.12%)  5/55 (9.09%)  8/104 (7.69%) 
Procedural pain  1  0/49 (0.00%)  3/55 (5.45%)  3/104 (2.88%) 
Investigations       
Alanine aminotransferase increased  1  3/49 (6.12%)  1/55 (1.82%)  4/104 (3.85%) 
Blood cortisol decreased  1  3/49 (6.12%)  1/55 (1.82%)  4/104 (3.85%) 
Blood glucose increased  1  4/49 (8.16%)  9/55 (16.36%)  13/104 (12.50%) 
Electrocardiogram QT prolonged  1  3/49 (6.12%)  1/55 (1.82%)  4/104 (3.85%) 
Gamma-glutamyltransferase increased  1  3/49 (6.12%)  4/55 (7.27%)  7/104 (6.73%) 
Insulin-like growth factor decreased  1  5/49 (10.20%)  5/55 (9.09%)  10/104 (9.62%) 
Weight decreased  1  3/49 (6.12%)  2/55 (3.64%)  5/104 (4.81%) 
Metabolism and nutrition disorders       
Decreased appetite  1  6/49 (12.24%)  1/55 (1.82%)  7/104 (6.73%) 
Diabetes mellitus  1  9/49 (18.37%)  14/55 (25.45%)  23/104 (22.12%) 
Hypercholesterolaemia  1  1/49 (2.04%)  3/55 (5.45%)  4/104 (3.85%) 
Hyperglycaemia  1  19/49 (38.78%)  22/55 (40.00%)  41/104 (39.42%) 
Hypoglycaemia  1  4/49 (8.16%)  3/55 (5.45%)  7/104 (6.73%) 
Hypokalaemia  1  1/49 (2.04%)  3/55 (5.45%)  4/104 (3.85%) 
Type 2 diabetes mellitus  1  5/49 (10.20%)  3/55 (5.45%)  8/104 (7.69%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/49 (4.08%)  5/55 (9.09%)  7/104 (6.73%) 
Back pain  1  1/49 (2.04%)  4/55 (7.27%)  5/104 (4.81%) 
Muscle spasms  1  2/49 (4.08%)  3/55 (5.45%)  5/104 (4.81%) 
Myalgia  1  3/49 (6.12%)  1/55 (1.82%)  4/104 (3.85%) 
Pain in extremity  1  5/49 (10.20%)  3/55 (5.45%)  8/104 (7.69%) 
Nervous system disorders       
Dizziness  1  6/49 (12.24%)  8/55 (14.55%)  14/104 (13.46%) 
Headache  1  12/49 (24.49%)  19/55 (34.55%)  31/104 (29.81%) 
Presyncope  1  3/49 (6.12%)  1/55 (1.82%)  4/104 (3.85%) 
Syncope  1  3/49 (6.12%)  0/55 (0.00%)  3/104 (2.88%) 
Psychiatric disorders       
Anxiety  1  2/49 (4.08%)  3/55 (5.45%)  5/104 (4.81%) 
Depression  1  4/49 (8.16%)  3/55 (5.45%)  7/104 (6.73%) 
Insomnia  1  1/49 (2.04%)  4/55 (7.27%)  5/104 (4.81%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  4/49 (8.16%)  7/55 (12.73%)  11/104 (10.58%) 
Hyperhidrosis  1  0/49 (0.00%)  3/55 (5.45%)  3/104 (2.88%) 
Pruritus  1  1/49 (2.04%)  3/55 (5.45%)  4/104 (3.85%) 
Rash  1  2/49 (4.08%)  4/55 (7.27%)  6/104 (5.77%) 
Vascular disorders       
Hypertension  1  3/49 (6.12%)  4/55 (7.27%)  7/104 (6.73%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01582061     History of Changes
Other Study ID Numbers: CSOM230B2406
First Submitted: April 12, 2012
First Posted: April 20, 2012
Results First Submitted: January 26, 2018
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018