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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191360
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007

September 12, 2005
November 5, 2007
January 2003
Not Provided
Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency
Not Provided
Complete list of historical versions of study NCT00191360 on ClinicalTrials.gov Archive Site
Maintenance of efficacy of growth hormone replacement, measured by lean body mass, which is achieved in the previous trial in adult patients wtih growth hormone deficiency
Not Provided
Not Provided
Not Provided
 
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency
Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Adult Growth Hormone Deficiency
Drug: Somatropin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2006
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00191360
6018, B9R-JE-K03A
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP