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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005852-42 | Registry Identifier | EudraCT |
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This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sandostatin LAR high dose Alone | Active Comparator | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. |
|
| Sandostatin LAR high dose + Pegvisomat | Experimental | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months |
|
| Sandostatin LAR high dose + Cabergoline | Experimental | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sandostatin LAR | Drug | 40 mg intramuscular (i.m.) every 28 days for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Complete Response (CR) at 8 Months | A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:
| From Baseline to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Complete Response (CR) At 3 Months | A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:
| From Baseline to 3 months |
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Inclusion Criteria:
• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Brest | 29609 | France | |||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sandostatin LAR High Dose Alone | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| pegvisomant | Drug | Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months |
|
|
| cabergoline | Drug | Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows:
|
|
|
| The Percentage of Participants With Partial Response (PR) at 8 Months | Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.
| From Baseline to 8 months |
| Bron |
| 69677 |
| France |
| Novartis Investigative Site | Le Kremlin-Bicêtre | 94275 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Nîmes | 30029 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Genova | 16132 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novarts Investigative Site | Naples | Italy |
| Novartis Investigative Site | Padova | Italy |
| Novartis Investigative Site | Perugia | 06126 | Italy |
| Novartis Investigative Site | Pisa | 56124 | Italy |
| Novartis Investigative Site | Torino | 10126 | Italy |
| Novartis Investigative Site | Lodz | 91-425 | Poland |
| Novartis Investigative Site | Warsaw | Poland |
| Novartis Investigative Site | Wroclaw | Poland |
| Novartis Investigative Site | Zabrze | 41-800 | Poland |
| Novartis Investigative Site | Porto | 4200-319 | Portugal |
| Novartis Investigative Site | Lausanne | CH-1011 | Switzerland |
| Sandostatin LAR High Dose + Pegvisomat |
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months. |
| FG002 | Sandostatin LAR High Dose + Cabergoline | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sandostatin LAR High Dose Alone | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. |
| BG001 | Sandostatin LAR High Dose + Pegvisomat | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months. |
| BG002 | Sandostatin LAR High Dose + Cabergoline | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
|
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Participants With Complete Response (CR) at 8 Months | A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:
| Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR | Posted | Number | 95% Confidence Interval | percent | From Baseline to 8 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With Complete Response (CR) At 3 Months | A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:
| Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR | Posted | Number | 95% Confidence Interval | percent | From Baseline to 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With Partial Response (PR) at 8 Months | Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.
| Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR | Posted | Number | 95% Confidence Interval | percent | From Baseline to 8 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sandostatin LAR High Dose Alone | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months | 0 | 7 | 4 | 7 | ||
| EG001 | Sandostatin LAR High Dose + Pegvisomant | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months. | 1 | 32 | 15 | 32 | ||
| EG002 | Sandostatin LAR High Dose + Cabergoline | All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
| 2 | 31 | 12 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood insulin decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
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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 (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| C406545 | pegvisomant |
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
|
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
|
|
|
| OG002 |
| Sandostatin LAR High Dose + Cabergoline |
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
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