NCT01582061 (SEASCAPE) is a Phase 3 clinical trial of Pasireotide sub-cutaneous in Cushing's Disease, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01582061?

NCT01582061 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01582061?

Interventions in NCT01582061: Pasireotide sub-cutaneous.

What condition does NCT01582061 study?

NCT01582061 studies Cushing's Disease.

Is NCT01582061 still recruiting?

NCT01582061 is currently completed. Last updated 19 June 2018.

Are results published for NCT01582061?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-19 · How we verify

NCT01582061: SEASCAPE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 19 June 2018

What this trial tests

Phase 3 trial testing Pasireotide sub-cutaneous in Cushing's Disease in 104 participants. Completed in 26 January 2017.

Timeline

16 August 2011

Primary endpoint
26 January 2017

26 January 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	16 August 2011
Primary completion	26 January 2017
Estimated completion	26 January 2017
Sites	65 locations across Russia, Greece, Germany, South Korea, Romania, Thailand, Lebanon, Spain

Drugs / interventions tested

Pasireotide sub-cutaneous — full drug profile →

Conditions studied

Cushing's Disease — all drugs for Cushing's Disease →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Cushing's 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 Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) Primary · Baseline up to approximately 256 weeks

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.

Any primary system organ class

Group	Value	95% CI
600 µg Bid - All Grades	53.1
600 μg - Grades 3/4	53.1
900 μg - All Grades	29.1
900 μg - Grades 3/4	27.3
All Patients - All Grades	40.4
All Patients - Grades 3/4	39.4

Metabolism and nutrition disorders

Group	Value	95% CI
600 µg Bid - All Grades	26.5
600 μg - Grades 3/4	26.5
900 μg - All Grades	12.7
900 μg - Grades 3/4	10.9
All Patients - All Grades	19.2
All Patients - Grades 3/4	18.3

Gastrointestinal disorders

Group	Value	95% CI
600 µg Bid - All Grades	18.4
600 μg - Grades 3/4	18.4
900 μg - All Grades	7.3
900 μg - Grades 3/4	7.3
All Patients - All Grades	12.5
All Patients - Grades 3/4	12.5

Investigations

Group	Value	95% CI
600 µg Bid - All Grades	8.2
600 μg - Grades 3/4	8.2
900 μg - All Grades	3.6
900 μg - Grades 3/4	3.6
All Patients - All Grades	5.8
All Patients - Grades 3/4	5.8

Hepatobiliary disorders

Group	Value	95% CI
600 µg Bid - All Grades	2.0
600 μg - Grades 3/4	2.0
900 μg - All Grades	5.5
900 μg - Grades 3/4	5.5
All Patients - All Grades	3.8
All Patients - Grades 3/4	3.8

Endocrine disorders

Group	Value	95% CI
600 µg Bid - All Grades	6.1
600 μg - Grades 3/4	6.1
900 μg - All Grades	0
900 μg - Grades 3/4	0
All Patients - All Grades	2.9
All Patients - Grades 3/4	2.9

Gen disorders,admin site conditions

Group	Value	95% CI
600 µg Bid - All Grades	4.1
600 μg - Grades 3/4	4.1
900 μg - All Grades	0
900 μg - Grades 3/4	0
All Patients - All Grades	1.9
All Patients - Grades 3/4	1.9

Ear and labyrinth disorders

Group	Value	95% CI
600 µg Bid - All Grades	2.0
600 μg - Grades 3/4	2.0
900 μg - All Grades	0
900 μg - Grades 3/4	0
All Patients - All Grades	1.0
All Patients - Grades 3/4	1.0

Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) Secondary · Baseline, week 12, 24 and 48

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 pri

Week 12

Group	Value	95% CI
Pasireotide 600 μg	77.8	57.74 – 91.38
Pasireotide 900 μg	38.5	23.36 – 55.38
All Patients	54.5	41.81 – 66.86

Week 24

Group	Value	95% CI
Pasireotide 600 μg	68.2	45.13 – 86.14
Pasireotide 900 μg	29.2	12.62 – 51.09
All Patients	47.8	32.89 – 63.05

Week 48

Group	Value	95% CI
Pasireotide 600 μg	70.0	34.75 – 93.33
Pasireotide 900 μg	18.2	2.28 – 51.78
All Patients	42.9	21.82 – 65.98

Week 24 (LOCF)

Group	Value	95% CI
Pasireotide 600 μg	54.1	36.92 – 70.51
Pasireotide 900 μg	28.6	16.59 – 43.26
All Patients	39.5	29.15 – 50.66

Week 48 (LOCF)

Group	Value	95% CI
Pasireotide 600 μg	51.4	34.40 – 68.08
Pasireotide 900 μg	22.4	11.78 – 36.62
All Patients	34.9	24.92 – 45.92

Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline Secondary · Baseline, week 12, 24 and 48

Week 12

Group	Value	95% CI
Pasireotide 600 μg	74.1	53.72 – 88.89
Pasireotide 900 μg	48.7	32.42 – 65.22
All Patients	59.1	46.29 – 71.05

Week 24

Group	Value	95% CI
Pasireotide 600 μg	68.2	45.13 – 86.14
Pasireotide 900 μg	33.3	15.63 – 55.32
All Patients	50.00	34.90 – 65.10

Week 48

Group	Value	95% CI
Pasireotide 600 μg	60.0	26.24 – 87.84
Pasireotide 900 μg	54.5	23.38 – 83.25
All Patients	57.1	34.02 – 78.18

Week 24 (LOCF)

Group	Value	95% CI
Pasireotide 600 μg	56.8	39.49 – 72.90
Pasireotide 900 μg	38.8	25.20 – 53.76
All Patients	46.5	35.68 – 57.59

Week 48 (LOCF)

Group	Value	95% CI
Pasireotide 600 μg	51.4	34.40 – 68.08
Pasireotide 900 μg	42.9	28.82 – 57.79
All Patients	46.5	35.68 – 57.59

Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores Secondary · Baseline, week 12, 24 and 48

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

Week 12

Group	Value	95% CI
Pasireotide 600 μg	21.3	± 47.03
Pasireotide 900 μg	100.8	± 252.25
All Patients	67.1	± 197.09

Week 24

Group	Value	95% CI
Pasireotide 600 μg	36.7	± 59.25
Pasireotide 900 μg	119.7	± 321.61
All Patients	82.3	± 243.19

Week 48

Group	Value	95% CI
Pasireotide 600 μg	24.0	± 37.76
Pasireotide 900 μg	42.3	± 60.75
All Patients	34.4	± 52.29

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP) Secondary · Baseline, week 12, 24 and 48

Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.

Sitting systolic Week 12

Group	Value	95% CI
Pasireotide 600 μg	-6.8	± 12.04
Pasireotide 900 μg	-1.4	± 14.40
All Patients	-3.8	± 13.61

Sitting systolic Week 24

Group	Value	95% CI
Pasireotide 600 μg	-7.4	± 8.97
Pasireotide 900 μg	-5.7	± 11.09
All Patients	-6.5	± 10.13

Sitting systolic Week 48

Group	Value	95% CI
Pasireotide 600 μg	-5.1	± 8.57
Pasireotide 900 μg	-4.7	± 12.55
All Patients	-4.9	± 10.87

Standing systolic Week 12

Group	Value	95% CI
Pasireotide 600 μg	-7.9	± 12.49
Pasireotide 900 μg	-3.6	± 15.38
All Patients	-5.5	± 14.27

Standing systolic Week 24

Group	Value	95% CI
Pasireotide 600 μg	-10.9	± 10.30
Pasireotide 900 μg	-6.7	± 14.09
All Patients	-8.6	± 12.62

Standing systolic Week 48

Group	Value	95% CI
Pasireotide 600 μg	-6.5	± 9.45
Pasireotide 900 μg	-4.4	± 13.86
All Patients	-5.3	± 12.10

Sitting diastolic Week 12

Group	Value	95% CI
Pasireotide 600 μg	-4.6	± 15.13
Pasireotide 900 μg	-0.2	± 14.40
All Patients	-2.1	± 14.79

Sitting diastolic Week 24

Group	Value	95% CI
Pasireotide 600 μg	-6.2	± 7.29
Pasireotide 900 μg	-3.8	± 15.83
All Patients	-4.9	± 12.65

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse Secondary · Baseline, week 12, 24 and 48

Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)\*100

Sitting pulse Week 12

Group	Value	95% CI
Pasireotide 600 μg	2.3	± 18.93
Pasireotide 900 μg	-7.5	± 11.50
All Patients	-3.2	± 15.87

Sitting pulse Week 24

Group	Value	95% CI
Pasireotide 600 μg	-1.8	± 17.05
Pasireotide 900 μg	-2.6	± 18.07
All Patients	-2.2	± 17.46

Sitting pulse Week 48

Group	Value	95% CI
Pasireotide 600 μg	2.9	± 16.39
Pasireotide 900 μg	3.7	± 15.46
All Patients	3.3	± 15.65

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature Secondary · Baseline week 12, 24 and 48

degrees celius

Week 12

Group	Value	95% CI
600 µg Bid - All Grades	0.1	± 1.26
900 μg - All Grades	-0.3	± 1.06
All Patients - All Grades	-0.1	± 1.17

Week 24

Group	Value	95% CI
600 µg Bid - All Grades	-0.1	± 1.15
900 μg - All Grades	-0.1	± 1.26
All Patients - All Grades	-0.1	± 1.20

Week 48

Group	Value	95% CI
600 µg Bid - All Grades	0.03	± 1.47
900 μg - All Grades	-0.1	± 1.19
All Patients - All Grades	0.1	± 1.31

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI) Secondary · Baseline, week 12, 24 and 48

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

Week 12

Group	Value	95% CI
Pasireotide 600 μg	-4.2	± 3.70
Pasireotide 900 μg	-4.8	± 5.38
All Patients	-4.5	± 4.69

Week 24

Group	Value	95% CI
Pasireotide 600 μg	-7.3	± 5.46
Pasireotide 900 μg	-5.2	± 6.51
All Patients	-6.1	± 6.10

Week 48

Group	Value	95% CI
Pasireotide 600 μg	-8.0	± 6.82
Pasireotide 900 μg	-6.3	± 7.88
All Patients	-7.0	± 7.39

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight Secondary · Baseline, week 12, 24 and 48

Clinically relevant threshold (at any time point) was reduction of ≥ 5%

Week 12

Group	Value	95% CI
Pasireotide 600 μg	-4.2	± 3.70
Pasireotide 900 μg	-4.8	± 5.38
All Patients	-4.5	± 4.69

Week 24

Group	Value	95% CI
Pasireotide 600 μg	-7.3	± 5.46
Pasireotide 900 μg	-5.2	± 6.51
All Patients	-6.1	± 6.10

Week 48

Group	Value	95% CI
Pasireotide 600 μg	-8.0	± 6.82
Pasireotide 900 μg	-6.3	± 7.88
All Patients	-7.0	± 7.39

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength Secondary · Baseline, week 12, 24 and 48

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

Week 12

Group	Value	95% CI
Pasireotide 600 μg	-34.6	± 62.53
Pasireotide 900 μg	-53.7	± 46.98
All Patients	-42.4	± 56.28

Week 24

Group	Value	95% CI
Pasireotide 600 μg	-28.6	± 48.80
Pasireotide 900 μg	-47.6	± 50.40
All Patients	-38.1	± 48.67

Week 48

Group	Value	95% CI
Pasireotide 600 μg	-30.0	± 44.72
Pasireotide 900 μg	-75.0	± 50.0
All Patients	-50.0	± 50.00

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference Secondary · Baseline, week 12, 24 and 48

Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%

Week 12

Group	Value	95% CI
Pasireotide 600 μg	-2.0	± 4.29
Pasireotide 900 μg	-2.9	± 6.70
All Patients	-2.5	± 5.72

Week 24

Group	Value	95% CI
Pasireotide 600 μg	-5.8	± 6.28
Pasireotide 900 μg	-3.1	± 5.48
All Patients	-4.4	± 5.96

Week 48

Group	Value	95% CI
Pasireotide 600 μg	-5.1	± 5.74
Pasireotide 900 μg	-4.1	± 5.64
All Patients	-4.6	± 5.62

Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism Secondary · Baseline, week 12, 24 and 48

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.

Week 12

Group	Value	95% CI
Pasireotide 600 μg	-12.2	± 24.57
Pasireotide 900 μg	-8.2	± 35.30
All Patients	-10.0	± 30.88

Week 24

Group	Value	95% CI
Pasireotide 600 μg	-21.2	± 32.72
Pasireotide 900 μg	-16.2	± 46.99
All Patients	18.4	± 40.79

Week 48

Group	Value	95% CI
Pasireotide 600 μg	-18.2	± 30.12
Pasireotide 900 μg	9.6	± 143.83
All Patients	-2.2	± 110.20

Adverse events — posted to ClinicalTrials.gov

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. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

600 µg Bid

Serious: 13/49 (27%)

Deaths: 0/49

900 µg Bid

Serious: 17/55 (31%)

Deaths: 1/55

All Patients

Serious: 30/104 (29%)

Deaths: 1/104

Serious adverse events (41 terms)

Reaction	System	600 µg Bid	900 µg Bid	All Patients
Diarrhoea	Gastrointestinal disorders	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—
Glucocorticoid deficiency	Endocrine disorders	—	—	—
Hyperprolactinaemia	Endocrine disorders	—	—	—
Pituitary-dependent Cushing's syndrome	Endocrine disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Gastrointestinal ulcer	Gastrointestinal disorders	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Pancreatitis necrotising	Gastrointestinal disorders	—	—	—
Death	General disorders	—	—	—
Drug ineffective	General disorders	—	—	—
Bile duct stone	Hepatobiliary disorders	—	—	—
Cholangitis acute	Hepatobiliary disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Hepatic lesion	Hepatobiliary disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Dengue fever	Infections and infestations	—	—	—
Meningitis	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—

Other adverse events (60 terms — click to expand)

Reaction	System	600 µg Bid	900 µg Bid	All Patients
Diarrhoea	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Fatigue	General disorders	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Blood glucose increased	Investigations	—	—	—
Oedema peripheral	General disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Insulin-like growth factor decreased	Investigations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Procedural nausea	Injury, poisoning and procedural complications	—	—	—
Type 2 diabetes mellitus	Metabolism and nutrition disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Bradycardia	Cardiac disorders	—	—	—
Sinus bradycardia	Cardiac disorders	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Faeces soft	Gastrointestinal disorders	—	—	—
Frequent bowel movements	Gastrointestinal disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Hepatic steatosis	Hepatobiliary disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—

Most-reported serious reactions: Diarrhoea, Cholecystitis acute, Diabetes mellitus, Hyperglycaemia, Hypokalaemia, Anaemia, Atrial fibrillation, Adrenal insufficiency.

Data from ClinicalTrials.gov NCT01582061 adverse events section.

Sponsor's own description

This study provided access to pasireotide sc in patients with Cushing's disease.and provided additional information for safety and efficacy of pasireotide s.c.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Medical Treatment of Cushing's Disease: An Overview of the Current and Recent Clinical Trials.
Pivonello R, Ferrigno R, De Martino MC, Simeoli C, et al · · 2020 · cited 84× · PMID 33363514 · DOI 10.3389/fendo.2020.00648
Safety and Efficacy of Subcutaneous Pasireotide in Patients With Cushing's Disease: Results From an Open-Label, Multicenter, Single-Arm, Multinational, Expanded-Access Study.
Fleseriu M, Iweha C, Salgado L, Mazzuco TL, et al · · 2019 · cited 13× · PMID 31379734 · DOI 10.3389/fendo.2019.00436

Verify or expand the search:

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Other Novartis Pharmaceuticals trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01582061 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 19 June 2018

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/NCT01582061.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01582061: SEASCAPE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (41 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Cushing's Disease

Other Novartis Pharmaceuticals trials

Verify against primary sources