Trial · NCT04467697
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | 120 days | Extension Treated Set | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | 90 days | Modified Extension Treated Set | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | 120 and 180 days | Extension Treated Set | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | 120 and 180 days | Extension Treated Set | bpm | LEAST_SQUARES_MEAN |
| SECONDARY | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | mmHg | MEAN |
| SECONDARY | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | mmHg | MEAN |
| SECONDARY | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 120 and 180 days | Extension Treated Set | bpm | MEAN |
| SECONDARY | Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Modified Extension Treatment Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Modified Extension Treatment Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | 180 days | Extension Treated Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Baseline, 90, 119 and 179 days | Extension Treated Set | mmHg | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Baseline, 90, 119 and 179 days | Extension Treated Set | beats/minute | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | 90 and 180 days | Extension Treated Set | U/L | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | 90 and 180 days | Extension Treated Set | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Extension Treated Set | g/dL | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Hormone Levels. | 90 and 180 days | Extension Treated Set | mIU/mL | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Hormone Levels for SHBG. | 90 and 180 days | Extension Treated Set | nmol/L | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Thyrotropin | 90 and 180 days | Extension Treated Set | mU/L | MEAN |
| OTHER_PRE_SPECIFIED | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Extension Treated Set | mg/dL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04467697/outcomes