Trial · NCT00570492
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period | Centimeters per year (cm/year) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean 24-hour Urinary Free Cortisol Excretion | Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60) | Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value \<1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis. | Micrograms per 24 hours (mcg/24 hours) | MEAN |
| SECONDARY | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons. | participants | NUMBER |
| SECONDARY | Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | International Units per liter (IU/L) | MEAN |
| SECONDARY | Mean Values for the Laboratory Parameters if Albumin and Total Protein | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Micromoles (µmol)/L | MEAN |
| SECONDARY | Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Millimoles (mmol)/L | MEAN |
| SECONDARY | Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Giga (10^9) cells (Gi)/L | MEAN |
| SECONDARY | Mean Values for Hemoglobin | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | g/L | MEAN |
| SECONDARY | Mean Values for Hematocrit | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Percentage of BV occupied by RBCs | MEAN |
| SECONDARY | Mean Hematology Values for Red Blood Cells (RBCs) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Trillion (10^12) cells (Ti)/L | MEAN |
| SECONDARY | Mean Values for Urine pH | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | scores on a scale | MEAN |
| SECONDARY | Mean Values for Urine Specific Gravity | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | ratio | MEAN |
| SECONDARY | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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