Trial · NCT05518149
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI) | From start of open-label treatment (Day 1) up to Week 52 | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the end of OL treatment phase. TEAEs included both serious and non serious AEs. AESI was defined as adverse events that were considered to be of special interest in this study. |
| Primary | Follow-up Phase: Number of Participants With Adverse Events (AEs) and AEs of Special Interest (AESI) | From Week 52 to Week 54 | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. AESI was defined as adverse events that were considered to be of special interest in this study. |
| Primary | Change From Baseline in Vital Sign Parameter: Blood Pressure (Systolic and Diastolic Blood Pressure) | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]) | Change from baseline in vital sign parameter (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | Change From Baseline in Vital Sign Parameter: Pulse Rate | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]) | Change from baseline in vital sign parameter (pulse rate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | Change From Baseline in Vital Sign Parameter: Temperature | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]) | Change from baseline in vital sign parameter (temperature) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | Change From Baseline in Vital Sign Parameter: Weight | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]) | Change from baseline in vital sign parameter (weight) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | Change From Baseline in Body Mass Index (BMI) | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]) | Change from baseline in BMI was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by Columbia Suicidality Severity Rating Scale (C-SSRS) | Baseline (DB, Day 1) up to Endpoint (OL) (at any time between Week 4 to Week 52) (Up to Week 58 from DB baseline) | C-SSRS was a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent). Suicidal behavior was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt \[non-fatal\]), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation(1-5), suicidal behavior(6-10). Total score ranged from 0 to 10. Higher scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported. |
| Primary | Follow-up Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by C-SSRS | Baseline (DB, Day 1), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52]) (maximum up to Week 54 from OL baseline and Week 60 from DB baseline) | C-SSRS was a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent). Suicidal behavior was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt \[non-fatal\]), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation(1-5), suicidal behavior(6-10). Total score ranged from 0 to 10. Higher scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameters: Albumin, Protein, Erythrocyte (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameters (albumin, protein, Ery. mean corpuscular HGB concentration, hemoglobin) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameters (bicarbonate, calcium, chloride, cholesterol, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphate, potassium, sodium, triglycerides, urea nitrogen) was reported. Baseline (OL) was defined as the assessment taken on or prior to this first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin, Urate | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameters (bilirubin, creatinine, direct bilirubin, indirect bilirubin, urate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, Leukocytes | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameters (basophils, eosinophils, lymphocytes, monocytes, platelets, leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameter (Ery. MCH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV) | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameter (Ery. MCV) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameter (hematocrit) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameter (specific gravity) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameter (urine pH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
| Primary | OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts | Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52) | Change from baseline in laboratory parameter (hyaline casts) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05518149/registered