Trial · NCT00994214
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
NCT00994214, Phase 2, Terminated, Ipsen; results first posted 2016-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly. Trials, record NCT00994214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00994214
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
- NCT number
- NCT00994214
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Acromegaly
- Interventions
- BIM 23A760
- First posted
- 2009-10-14
- Last updated
- 2019-11-22
- Other registries' IDs
- eudract:2009-010787-42
- Results first posted
- 2016-02-10
- Limitations and caveats
- The study was terminated prematurely due to lack of efficacy.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 6 | |
| Secondary | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 3 | |
| Secondary | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 1 | |
| Secondary | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 | Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline |
| Secondary | Changes in IGF-1 | Baseline (Day 1) and Month 6 | |
| Secondary | Percentage Change in Ring Finger Circumference | Baseline (Day 1) and Month 6 | Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline. |
| Secondary | Number of Subjects Reported Adverse Events During the Study | Up to Visit 10 (An average of 6.5 Months) | For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe \> moderate \> mild) and the most serious causality (related \> not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 6 | Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9). | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 3 | ITT population. N=Number of subjects attended Month 3 (visit 7). | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 1 | ITT population. N=Number of subjects attended Month 1 (visit 5). | Percentage of subjects | NUMBER |
| SECONDARY | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 | N=Number of patients randomised to treatment in IGF-1 \<2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum. | Percentage of change in mean GH | MEAN |
| SECONDARY | Changes in IGF-1 | Baseline (Day 1) and Month 6 | ITT population | Percentage of ULN | MEAN |
| SECONDARY | Percentage Change in Ring Finger Circumference | Baseline (Day 1) and Month 6 | ITT population. N=Number of subjects attended Month 6 (visit 9). | Percentage of Change in Ring Finger circ | MEAN |
| SECONDARY | Number of Subjects Reported Adverse Events During the Study | Up to Visit 10 (An average of 6.5 Months) | Safety Population~Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group113
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm A: BIM 23A760 1 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm B: BIM 23A760 2 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm C: BIM 23A760 4 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm D: BIM 23A760 6 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm A: BIM 23A760 1 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 83.3 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm B: BIM 23A760 2 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100.0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm C: BIM 23A760 4 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100.0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm D: BIM 23A760 6 mg | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100.0 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm A: BIM 23A760 1 mg | Missing | 16.7 | Percentage of subjects | |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Arm B: BIM 23A760 2 mg | Missing | 0 | Percentage of subjects |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| ITT (Intention-to-Treat) - Part A | STARTED | Arm A: BIM 23A760 1 mg | 19 | |
| ITT (Intention-to-Treat) - Part A | STARTED | Arm B: BIM 23A760 2 mg | 19 | |
| ITT (Intention-to-Treat) - Part A | STARTED | Arm C: BIM 23A760 4 mg | 18 | |
| ITT (Intention-to-Treat) - Part A | STARTED | Arm D: BIM 23A760 6 mg | 20 | |
| ITT (Intention-to-Treat) - Part A | COMPLETED | Arm A: BIM 23A760 1 mg | 5 | |
| ITT (Intention-to-Treat) - Part A | COMPLETED | Arm B: BIM 23A760 2 mg | 6 | |
| ITT (Intention-to-Treat) - Part A | COMPLETED | Arm C: BIM 23A760 4 mg | 5 | |
| ITT (Intention-to-Treat) - Part A | COMPLETED | Arm D: BIM 23A760 6 mg | 5 | |
| ITT (Intention-to-Treat) - Part A | NOT COMPLETED | Arm A: BIM 23A760 1 mg | 14 | |
| ITT (Intention-to-Treat) - Part A | NOT COMPLETED | Arm B: BIM 23A760 2 mg | 13 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events801
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Part A: Arm A: BIM 23A760 1 mg | 1 | 19 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Part A: Arm B: BIM 23A760 2 mg | 0 | 19 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Part A: Arm C: BIM 23A760 4 mg | 0 | 18 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Part A: Arm D: BIM 23A760 6 mg | 2 | 20 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Overall - Part A | 3 | 76 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B: Arm B: BIM 23A760 2 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B: Arm C: BIM 23A760 4 mg | 0 | 4 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B: Arm D: BIM 23A760 6 mg | 0 | 5 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Overall - Part B | 0 | 12 | 0 |
| other | PANCYTOPENIA | Blood and lymphatic system disorders | Part A: Arm A: BIM 23A760 1 mg | 0 | 19 | 0 |
1 to 10 of 801Source ClinicalTrials.gov
See all 801 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Arm A: BIM 23A760 1 mg | ||
| Total, all-cause mortality | Part A: Arm B: BIM 23A760 2 mg | ||
| Total, all-cause mortality | Part A: Arm C: BIM 23A760 4 mg | ||
| Total, all-cause mortality | Part A: Arm D: BIM 23A760 6 mg | ||
| Total, all-cause mortality | Overall - Part A | ||
| Total, all-cause mortality | Part B: Arm B: BIM 23A760 2 mg | ||
| Total, all-cause mortality | Part B: Arm C: BIM 23A760 4 mg | ||
| Total, all-cause mortality | Part B: Arm D: BIM 23A760 6 mg | ||
| Total, all-cause mortality | Overall - Part B | ||
| Total, other adverse events | Part A: Arm A: BIM 23A760 1 mg | 11 | 19 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00994214
GET https://conductscience.org/api/trials/v1/NCT00994214/results?page=2