Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

Lilly

Status and phase: Completed; Phase 3

Conditions: Adult Growth Hormone Deficiency

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191360

6018

B9R-JE-K03A

Details and patient eligibility

About

To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having completed the preceding long-term study of growth hormone replacement in adult patients diagnosed with growth hormone deficiency.
• Other pituitary hormone deficiencies being replaced if appropriate

Exclusion criteria

• With severe impairments of cardiac, pulmonary, renal or hepatic functions
• With severe psychological disorders
• With malignant cancer
• With hypertension uncontrolled
• With diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)