Recent Updates
Recently added Catalysts

Levothyroxine new formulation

Phase 2

Hypothyroidism | Small molecule | Endocrine |Takeda Pharmaceutical Company Limited|Last Updated: Jul 20, 2015

Target and mechanism

ModalitySmall molecule

Also known as Levothyroxine sodium new formulation

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

Levothyroxine new formulation · 1 trial · 1 indication

Phase 2 1
NCT01916304Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test FormulationHypothyroidism
COMPLETED101 Analytics
PHASE2COMPLETED
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Hypothyroidism
NCT01916304101
Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Magnitude of the Change in Daily Dose Needed
2 months (± 2 weeks) after switch to sodium formulation.
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.
Absolute Serum Thyroid Stimulating Hormone Values
Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Levothyroxine sodium new formulationEXPERIMENTALLevothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.

Interventions

NameTypeDescription
Levothyroxine sodium new formulationDRUGLevothyroxine tablets
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. (Near) total thyroidectomised patients. 2. Aged 18 years and older. 3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study. 4. Written informed consent given. 5. Able and willing to comply with protocol requireme...

Countries:Belgium
Unlock Eligibility Criteria