TriangleNCT04467697 · OUTCOME
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- bpm
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 120 and 180 days
What was measured
Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis.
Analysis population: Extension Treated Set
Groups in this outcome
SOV2012-F1-treated
Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
| Group | Source count |
|---|---|
| SOV2012-F1-treated | 139 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SOV2012-F1-treated | 76.3 | Not reported | 74.4 | 78.3 | Not reported |
Observed Visit 14E (Day 120E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SOV2012-F1-treated | 77.0 | Not reported | 75.1 | 79.0 | Not reported |
Change from baseline to Visit 14E (Day 120E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SOV2012-F1-treated | 0.7 | Not reported | -0.5 | 1.9 | Not reported |
Observed Visit 16E (Day 180E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SOV2012-F1-treated | 78.2 | Not reported | 76.2 | 80.2 | Not reported |
Change from baseline to Visit 16E (Day 180E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SOV2012-F1-treated | 1.9 | Not reported | 0.6 | 3.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.4
- upper Limit
- 78.3
- value
- 76.3
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75.1
- upper Limit
- 79.0
- value
- 77.0
- title
- Observed Visit 14E (Day 120E)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.5
- upper Limit
- 1.9
- value
- 0.7
- title
- Change from baseline to Visit 14E (Day 120E)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 76.2
- upper Limit
- 80.2
- value
- 78.2
- title
- Observed Visit 16E (Day 180E)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 3.1
- value
- 1.9
- title
- Change from baseline to Visit 16E (Day 180E)
- denoms
- counts
- group Id
- OG000
- value
- 139
- units
- Participants
- description
- Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
- id
- OG000
- title
- SOV2012-F1-treated
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Extension Treated Set
- reporting Status
- POSTED
- time Frame
- 120 and 180 days
- title
- Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
- type
- SECONDARY
- unit Of Measure
- bpm
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice