- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263509
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 When Used in Combination With α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
"To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion Criteria:
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
|
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other Names:
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other Names:
|
Experimental: Alogliptin 25 mg QD and Voglibose 0.2 mg TID
|
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other Names:
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events.
Time Frame: 52 Weeks.
|
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug.
A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.
|
52 Weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time Frame: Baseline and Week 8.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 8.
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time Frame: Baseline and Week 12.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 12.
|
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Time Frame: Baseline and Week 16.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 16.
|
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Time Frame: Baseline and Week 20.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 20.
|
Change From Baseline in Glycosylated Hemoglobin (Week 24).
Time Frame: Baseline and Week 24.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 24.
|
Change From Baseline in Glycosylated Hemoglobin (Week 28).
Time Frame: Baseline and Week 28.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 28.
|
Change From Baseline in Glycosylated Hemoglobin (Week 32).
Time Frame: Baseline and Week 32.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 32.
|
Change From Baseline in Glycosylated Hemoglobin (Week 36).
Time Frame: Baseline and Week 36.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 36.
|
Change From Baseline in Glycosylated Hemoglobin (Week 40).
Time Frame: Baseline and Week 40.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 40.
|
Change From Baseline in Glycosylated Hemoglobin (Week 44).
Time Frame: Baseline and Week 44.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 44.
|
Change From Baseline in Glycosylated Hemoglobin (Week 48).
Time Frame: Baseline and Week 48.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 48.
|
Change From Baseline in Glycosylated Hemoglobin (Week 52).
Time Frame: Baseline and Week 52.
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 52.
|
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
Time Frame: Baseline and Week 8.
|
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
|
Baseline and Week 8.
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
|
Baseline and Week 12.
|
Change From Baseline in Fasting Plasma Glucose (Week 16).
Time Frame: Baseline and Week 16.
|
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
|
Baseline and Week 16.
|
Change From Baseline in Fasting Plasma Glucose (Week 20).
Time Frame: Baseline and Week 20.
|
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
|
Baseline and Week 20.
|
Change From Baseline in Fasting Plasma Glucose (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
|
Baseline and Week 24.
|
Change From Baseline in Fasting Plasma Glucose (Week 28).
Time Frame: Baseline and Week 28.
|
The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
|
Baseline and Week 28.
|
Change From Baseline in Fasting Plasma Glucose (Week 32).
Time Frame: Baseline and Week 32.
|
The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
|
Baseline and Week 32.
|
Change From Baseline in Fasting Plasma Glucose (Week 36).
Time Frame: Baseline and Week 36.
|
The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
|
Baseline and Week 36.
|
Change From Baseline in Fasting Plasma Glucose (Week 40).
Time Frame: Baseline and Week 40.
|
The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
|
Baseline and Week 40.
|
Change From Baseline in Fasting Plasma Glucose (Week 44).
Time Frame: Baseline and Week 44.
|
The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
|
Baseline and Week 44.
|
Change From Baseline in Fasting Plasma Glucose (Week 48).
Time Frame: Baseline and Week 48.
|
The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
|
Baseline and Week 48.
|
Change From Baseline in Fasting Plasma Glucose (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
|
Baseline and Week 52.
|
Change From Baseline in Fasting Plasma Glucose (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in Fasting C-peptide (Week 8).
Time Frame: Baseline and Week 8.
|
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
|
Baseline and Week 8.
|
Change From Baseline in Fasting C-peptide (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
|
Baseline and Week 12.
|
Change From Baseline in Fasting C-peptide (Week 16).
Time Frame: Baseline and Week 16.
|
The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
|
Baseline and Week 16.
|
Change From Baseline in Fasting C-peptide (Week 20).
Time Frame: Baseline and Week 20.
|
The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
|
Baseline and Week 20.
|
Change From Baseline in Fasting C-peptide (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
|
Baseline and Week 24.
|
Change From Baseline in Fasting C-peptide (Week 28).
Time Frame: Baseline and Week 28.
|
The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
|
Baseline and Week 28.
|
Change From Baseline in Fasting C-peptide (Week 32).
Time Frame: Baseline and Week 32.
|
The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
|
Baseline and Week 32.
|
Change From Baseline in Fasting C-peptide (Week 36).
Time Frame: Baseline and Week 36.
|
The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
|
Baseline and Week 36.
|
Change From Baseline in Fasting C-peptide (Week 40).
Time Frame: Baseline and Week 40.
|
The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
|
Baseline and Week 40.
|
Change From Baseline in Fasting C-peptide (Week 44).
Time Frame: Baseline and Week 44.
|
The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
|
Baseline and Week 44.
|
Change From Baseline in Fasting C-peptide (Week 48).
Time Frame: Baseline and Week 48.
|
The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
|
Baseline and Week 48.
|
Change From Baseline in Fasting C-peptide (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
|
Baseline and Week 52.
|
Change From Baseline in Fasting C-peptide (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 12.
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 24.
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 52.
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 12.
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 24.
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 52.
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 12.
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 24.
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 52.
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 12.
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 24.
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 52.
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Final Visit (up to Week 52).
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
Time Frame: Baseline and Week 12.
|
The change between the value of glucagons collected at week 12 and glucagons collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 12.
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
Time Frame: Baseline and Week 24.
|
The change between the value of glucagons collected at week 24 and glucagons collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 24.
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
Time Frame: Baseline and Week 52.
|
The change between the value of glucagons collected at week 52 and glucagons collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 52.
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
Time Frame: Baseline and Final Visit (up to Week 52).
|
The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline.
Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Final Visit (up to Week 52).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Professor, Department of Medicine, Kawasaki Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Micronutrients
- Vitamins
- Incretins
- Vitamin B Complex
- Dipeptidyl-Peptidase IV Inhibitors
- Glycoside Hydrolase Inhibitors
- Inositol
- Alogliptin
- Voglibose
Other Study ID Numbers
- SYR-322/OCT-003
- U1111-1118-3992 (Registry Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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