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Trial · Interventional

CompletedPhase 1Registry data

Effects of Growth Hormone on the Nitric Oxide Pathway

NCTNCT00470002 (opens ClinicalTrials.gov in a new tab)Other idMES 03069Other idVP2-3900-4021576Other idIRB#3444
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
16 participants (actual)
Sponsor
Hannover Medical School · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
May 2004
Primary completion
Not stated
Completion
Jan 2005
First posted
7 May 2007 (estimated)
Last update posted
7 May 2007 (estimated)
Conditions
Cardiovascular Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006
  1. Ph 1

    Effects of Growth Hormone on the Nitric Oxide Pathway

    NCT00470002

    May 2004 to Jan 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to determine whether the treatment with growth hormone has an influence on the nitric oxide pathway in healthy males.

Interventions

  • SomatropinDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Urinary nitrate excretion

    Time frame · 10 days

Secondary outcomes(1)

  1. Insulin-like growth factor-1 in serum

    Time frame · 10 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1996

11 results

Nitric oxide may mediate the hemodynamic effects of recombinant growth hormone in patients with acquired growth hormone deficiency. A double-blind, placebo-controlled study.

Böger et al. 1996The Journal of clinical investigationcited by 177

PMID 8981915PMC507734DOI 10.1172/jci119095PUB-08981915

Rights unknown11 results
Source linkSee results (11)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy male subjects without recent severe diseases * Age 50 yrs or older * Body mass index at or below 30 kg/m2 * Insulin-like growth factor-1 level below 200 ng/ml * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial * Subjects that are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria: * History of any severe hepatic, renal, cardiac, endocrine, metabolic, or malignant diseases * Requirement for medical drug treatment * Growth hormone treatment during the last 12 months * Drug dependence, alcohol or nicotine abuse * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.

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