| Primary | Thyroid Stimulating Hormone (TSH) | Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline | intention to treat (ITT), 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | mIU/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | <0.0001 | level of significance p-value < 0.05 | Mean Difference (Final Values) | -0.783797 | Standard Error of the Mean | 0.158271 | 2-Sided | | | | | | | | Other | Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg). |
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| Secondary | Free Thyroxine (FT4) | Change in Serum Levels of FT4 (free thyroxine) from Baseline | ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | pmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Secondary | Total Thyroxine (TT4) | Change in Serum Levels of TT4 (total thyroxine) from Baseline | ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | nmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Secondary | Free Triiodothyronine (FT3) | Change in Serum Levels of FT3 (free triiodothyronine) from Baseline | ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | pmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Secondary | Total Triiodothyronine (TT3) | Change in Serum Levels of TT3 (total triiodothyronine) from Baseline | ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | nmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Creatine Phosphokinase (CPK) | Change in Serum Levels of creatine phosphokinase (CPK) from Baseline | ITT, 6 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | U/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Sex Hormone Binding Globulin (SHBG) | Change in Serum Levels of SHBG (sex hormone binding globuline) from Baseline | ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | nmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Ferritin | Change in Serum Levels of ferritin from Baseline | ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change | Posted | | Mean | Standard Deviation | mcg/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Angiotensin Converting Enzyme (ACE) | Change in Serum Levels of ACE (angiotensin converting enzyme) from Baseline | ITT, 9 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | U/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Triglycerides | Change in triglycerides levels from Baseline | ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | mmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Cholesterol, Total | Change in total cholesterol levels from Baseline | ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | mmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Low Density Lipoprotein (LDL)-Cholesterol | Change in low density lipoprotein (LDL)-cholesterol levels from baseline | ITT, 8 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | mmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | High Density Lipoprotein (HDL)-Cholesterol | Change in High Density Lipoprotein (HDL)-cholesterol levels from baseline | ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | mmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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| Other Pre-specified | Very Low Density Lipoprotein (VLDL)-Cholesterol | Change in Very Low Density Lipoprotein (VLDL)-cholesterol levels from baseline | ITT, 8 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed | Posted | | Mean | Standard Deviation | mmol/L | | baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Tirosint Capsules | During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion. |
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