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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01088399 |
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Date of registration:
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25/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults
HypoCCS |
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Scientific title:
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The Global Hypopituitary Control and Complications Study |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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10673 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01088399 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult growth hormone deficiency as per the local Humatrope label and as judged by the
attending physician
Exclusion Criteria:
- As per the local Humatrope label and as judged by the attending physician
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypopituitarism
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Growth Hormone Deficiency, Adult
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Pituitary Insufficiency
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Intervention(s)
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Drug: Somatropin (rDNA origin)
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Primary Outcome(s)
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Clinically Significant Adverse Events
[Time Frame: Baseline to study completion (approximately 10 years)]
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Secondary Outcome(s)
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Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).
[Time Frame: Baseline, interim time point (5 years), and study completion (10 years)]
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Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)
[Time Frame: Baseline through 10 years]
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Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)
[Time Frame: Baseline, interim time point (5 years), and study completion (10 years)]
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Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)
[Time Frame: Baseline, interim time point (5 years), and study completion (10 years)]
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Cardiovascular Risk Factor-Change From Baseline in Waist Circumference
[Time Frame: Baseline, interim time point (5 years), and study completion (10 years)]
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Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides
[Time Frame: Baseline, interim time point (5 years), and study completion (10 years)]
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Secondary ID(s)
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6448
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B9R-MC-GDGA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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