Trial · NCT02712320
Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
NCT02712320, Phase 3, Completed, Foresee Pharmaceuticals Co., Ltd.; results first posted 2018-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg. Trials, record NCT02712320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02712320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
- NCT number
- NCT02712320
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Conditions
- Prostatic Neoplasms
- Interventions
- LMIS 50 mg
- First posted
- 2016-03-18
- Last updated
- 2019-03-26
- Results first posted
- 2018-09-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Up to 48 weeks | Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events |
| Primary | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Up to 48 weeks | Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval. |
| Primary | Laboratory Assessments - Hematology | 48 weeks | Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c. |
| Primary | Laboratory Assessments - Biochemistry | 48 weeks | Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides. |
| Primary | Laboratory Assessments - Urinalysis | 48 weeks | Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Up to 48 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Up to 48 weeks | 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Laboratory Assessments - Hematology | 48 weeks | 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Laboratory Assessments - Biochemistry | 48 weeks | 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Laboratory Assessments - Urinalysis | 48 weeks | 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | LMIS 50 mg | TEAE | 12 | Participants | |
| Number of Participants With Adverse Events | LMIS 50 mg | Drug-related AE | 1 | Participants | |
| Number of Participants With Adverse Events | LMIS 50 mg | Serious Adverse Event (SAE) | 4 | Participants | |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | LMIS 50 mg | Overall Interpretation at Screening (V1) / Normal | 4 | Participants | |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | LMIS 50 mg | Overall Interpretation at Screening (V1) / Abnormal-No clinical significance | 25 | Participants | |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | LMIS 50 mg | Overall Interpretation on Day 168 (V4) / Normal | 2 | Participants | |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | LMIS 50 mg | Overall Interpretation on Day 168 (V4) / Abnormal-No clinical significance | 16 | Participants | |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | LMIS 50 mg | Overall Interpretation on Day 336 (V6/EOS) / Normal | 7 | Participants | |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | LMIS 50 mg | Overall Interpretation on Day 336 (V6/EOS) / Abnormal-No clinical significance | 20 | Participants | |
| Laboratory Assessments - Hematology | LMIS 50 mg | Hemoglobin (gm/dL) at Screening (V1) / Normal | 17 | Participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LMIS 50 mg | 30 | |
| Overall Study | COMPLETED | LMIS 50 mg | 25 | |
| Overall Study | NOT COMPLETED | LMIS 50 mg | 5 |
Source ClinicalTrials.gov
Adverse events9
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 | Fatigue | General disorders | LMIS 50 mg | 2 | 30 | 2 |
| other | Hypertension | Vascular disorders | LMIS 50 mg | 2 | 30 | 2 |
| serious | Perforated ulcer | General disorders | LMIS 50 mg | 1 | 30 | 1 |
| serious | Pyelonephritis acute | Infections and infestations | LMIS 50 mg | 1 | 30 | 1 |
| serious | Sepsis | Infections and infestations | LMIS 50 mg | 1 | 30 | 1 |
| serious | Hip fracture | Injury, poisoning and procedural complications | LMIS 50 mg | 1 | 30 | 1 |
| serious | Dyspnoea | Respiratory, thoracic and mediastinal disorders | LMIS 50 mg | 1 | 30 | 1 |
| serious | Knee arthroplasty | Surgical and medical procedures | LMIS 50 mg | 1 | 30 | 1 |
| serious | Deep vein thrombosis | Vascular disorders | LMIS 50 mg | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LMIS 50 mg | 0 | 30 |
| Total, other adverse events | LMIS 50 mg | 4 | 30 |
| Total, serious adverse events | LMIS 50 mg | 4 | 30 |
Source ClinicalTrials.gov
Papers0
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/NCT02712320
GET https://conductscience.org/api/trials/v1/NCT02712320/results?page=2