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NCT01698944 Clinical Trial

Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

Adult Growth Hormone Deficiency Clinical Trial

Official title:
Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01698944
Other study ID # GHDADULT-1112
Secondary ID
Status Terminated
Phase Phase 4
First received October 1, 2012
Last updated February 23, 2017
Start date May 16, 2001
Est. completion date November 18, 2002

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the effect of growth hormone on left ventricle morphology and function (systolic and diastolic).

Recruitment information / eligibility
Status Terminated
Enrollment 7
Est. completion date November 18, 2002
Est. primary completion date November 18, 2002
Accepts healthy volunteers No
Gender All
Age group 12 Years to 25 Years
Eligibility Inclusion Criteria:

- Adult growth hormone deficiency

- At least 2 years without growth hormone treatment

Exclusion Criteria:

- Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic

- Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Initial dose 0.5 IU/day and escalated up to maximum dose the first 6 months. Maximum dose 3.0 IU/day for 18 months. Injected subcutaneously (s.c., under the skin) daily

Locations
Country Name City State
Greece Novo Nordisk Investigational Site Athens

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Left Ventricular systolic function
Primary Left Ventricular diastolic function
Secondary Body composition
Secondary Fasting glucose
Secondary HbA1c (glycosylated haemoglobin)
Secondary Oral glucose tolerance test (OGTT)
See also
  Status Clinical Trial Phase
Completed NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. Phase 3
Completed NCT01562834 - Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Phase 4
Completed NCT01822340 - Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients Phase 2
Completed NCT01109017 - Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency N/A
Completed NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency Phase 1
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
Completed NCT02005198 - Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) N/A
Completed NCT01806298 - An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) Phase 4
Terminated NCT01909479 - A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency Phase 3
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Recruiting NCT05979480 - The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)
Completed NCT02526420 - Versartis International Trial in Adults With Long-Acting Growth Hormone Phase 2
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00715689 - Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 2
Completed NCT00297713 - Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Phase 2
Completed NCT01543880 - Safety and Efficacy of Long-term Somatropin Treatment in Adults N/A
Completed NCT01580605 - French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Not yet recruiting NCT04867317 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) Phase 3

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