Trial · NCT01916304
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
NCT01916304, Phase 2, Completed, Takeda; results first posted 2015-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation. Trials, record NCT01916304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01916304
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
- NCT number
- NCT01916304
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 101 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypothyroidism
- Interventions
- Levothyroxine sodium new formulation
- First posted
- 2013-08-05
- Last updated
- 2015-07-20
- Other registries' IDs
- eudract:2012-005732-28
- Results first posted
- 2015-07-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants That Do Not Need a Change of Dose | 2 months (± 2 weeks) after switch to sodium formulation. | Dose change was determined by physician according to their clinical judgement. |
| Secondary | Magnitude of the Change in Daily Dose Needed | 2 months (± 2 weeks) after switch to sodium formulation. | Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg. |
| Secondary | Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L | Month 4 (± 4 weeks) after inclusion into study. | Blood samples were collected and samples were analyzed according to the local Quality System. |
| Secondary | Absolute Serum Thyroid Stimulating Hormone Values | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. | Blood samples were collected and samples were analyzed according to the local Quality System. |
| Secondary | Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. | Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants That Do Not Need a Change of Dose | 2 months (± 2 weeks) after switch to sodium formulation. | Participants from the intent-to-treat population, with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Magnitude of the Change in Daily Dose Needed | 2 months (± 2 weeks) after switch to sodium formulation. | Participants from the intent-to-treat population, with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L | Month 4 (± 4 weeks) after inclusion into study. | Participants from the intent-to-treat population, with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Absolute Serum Thyroid Stimulating Hormone Values | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. | Participants from the intent-to-treat population, with data available for analysis. | mIU/mL | MEAN |
| SECONDARY | Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone | Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. | Participants from the intent-to-treat population, with data available for analysis. | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants That Do Not Need a Change of Dose | Levothyroxine Sodium New Formulation | 32.9 | 95% Confidence Interval 23.7 to 43.7 | percentage of participants | |
| Magnitude of the Change in Daily Dose Needed | Levothyroxine Sodium New Formulation | -25 μg change | 19.51 | percentage of participants | |
| Magnitude of the Change in Daily Dose Needed | Levothyroxine Sodium New Formulation | -12.5 μg change | 42.68 | percentage of participants | |
| Magnitude of the Change in Daily Dose Needed | Levothyroxine Sodium New Formulation | -6.25 μg change | 1.22 | percentage of participants | |
| Magnitude of the Change in Daily Dose Needed | Levothyroxine Sodium New Formulation | -5.35 μg change | 1.22 | percentage of participants | |
| Magnitude of the Change in Daily Dose Needed | Levothyroxine Sodium New Formulation | 0 μg change | 32.93 | percentage of participants | |
| Magnitude of the Change in Daily Dose Needed | Levothyroxine Sodium New Formulation | +12.5 μg change | 2.44 | percentage of participants | |
| Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L | Levothyroxine Sodium New Formulation | 57.3 | percentage of participants | ||
| Absolute Serum Thyroid Stimulating Hormone Values | Levothyroxine Sodium New Formulation | Baseline | 1.1 | Inter-Quartile Range 0.59 | mIU/mL |
| Absolute Serum Thyroid Stimulating Hormone Values | Levothyroxine Sodium New Formulation | Month 2 (n=83) | 0.3 | Inter-Quartile Range 1.69 | mIU/mL |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levothyroxine Sodium New Formulation | 101 | |
| Overall Study | Safety Set | Levothyroxine Sodium New Formulation | 101 | |
| Overall Study | Intent-to-Treat Set | Levothyroxine Sodium New Formulation | 84 | |
| Overall Study | COMPLETED | Levothyroxine Sodium New Formulation | 84 | |
| Overall Study | NOT COMPLETED | Levothyroxine Sodium New Formulation | 17 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Levothyroxine Sodium New Formulation | 7 | 101 | |
| serious | Cardiac failure | Cardiac disorders | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Post procedural haematoma | Injury, poisoning and procedural complications | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Catheterisation cardiac | Investigations | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Skin lesion | Skin and subcutaneous tissue disorders | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Bladder catheterisation | Surgical and medical procedures | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Hysterectomy | Surgical and medical procedures | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Mastectomy | Surgical and medical procedures | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Salivary gland resection | Surgical and medical procedures | Levothyroxine Sodium New Formulation | 1 | 101 | |
| serious | Haemorrhage | Vascular disorders | Levothyroxine Sodium New Formulation | 1 | 101 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levothyroxine Sodium New Formulation | ||
| Total, other adverse events | Levothyroxine Sodium New Formulation | 7 | 101 |
| Total, serious adverse events | Levothyroxine Sodium New Formulation | 7 | 101 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01916304
GET https://conductscience.org/api/trials/v1/NCT01916304/registered