Trial · NCT04467697
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | 120 days | Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis). |
| Primary | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | 90 days | Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1. |
| Secondary | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average systolic blood pressure (sBP) after 120 and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis). |
| 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 | Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average diastolic blood pressure (dBP) after 120 Days (+/-) and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis). |
| Secondary | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis. |
| 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 | Observed and change from baseline in Ambulatory half hourly systolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| 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 | Observed and change from baseline in Ambulatory half hourly diastolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| 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 | Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| 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 | Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1. |
| 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 | Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1. |
| Other | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | 180 days | Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects |
| Other | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Baseline, 90, 119 and 179 days | Measured by in-clinic BP measurement of sBP, mmHg, observed and change from baseline at baseline, 90, 120 and 180 days after treatment with SOV2012-F1. |
| Other | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Baseline, 90, 119 and 179 days | Measured by in-clinic HR measurement, beats per minute during the treatment period, at baseline, and after 90, 120 and 180 days of treatment with SOV2012-F1. |
| Other | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | 90 and 180 days | Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of Units per Liter (U/L) |
| Other | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | 90 and 180 days | Total bilirubin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL |
| Other | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Hemoglobin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of g/dL. |
| Other | Observed and Change From Baseline in Hormone Levels. | 90 and 180 days | Luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\] in SOV2012-F1 treated subjects during the treatment period, measurement units of mIU/mL. |
| Other | Observed and Change From Baseline in Hormone Levels for SHBG. | 90 and 180 days | Sex hormone-binding globulin \[SHBG\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of nmol/L. |
| Other | Observed and Change From Baseline in Thyrotropin | 90 and 180 days | Thyroid stimulating hormone \[TSH\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mU/L. |
| Other | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL. |
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.
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