Trial · NCT01342952
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 56
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Vital Sign Parameter: Height | Baseline (Day 1) and up to 10 years and 11 months | Height was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Vital Sign Parameter: Body Mass Index | Baseline (Day 1) and up to 10 years and 11 months | Body mass index was measured for the participants at indicated time points. Body mass index was calculated as weight in kilograms (kg) divided by the square of their height in meters (m\^2). Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Vital Sign Parameter: Body Surface Area | Baseline (Day 1) and up to 10 years and 11 months | Body surface area was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to 10 years and 11 months | 12-lead ECG was measured in a semi-supine position using an automated ECG machine. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Data for any time till end of study were presented. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at End of Study | Baseline (Day 1) and up to 10 years and 11 months | FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Inhibin B at End of Study | Baseline (Day 1) and up to 10 years and 11 months | Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Inhibin B at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Sex Hormone Binding Globulin at End of Study | Baseline (Day 1) and up to 10 years and 11 months | Sex hormone binding globulin level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Sex Hormone Binding Globulin at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | Sex hormone binding globulin level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Estrone at End of Study | Baseline (Day 1) and up to 10 years and 11 months | Estrone level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Estrone at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | Estrone level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Estriol at End of Study | Baseline (Day 1) and up to 10 years and 11 months | Estriol level of female participants will be measured. Only those parameters having status as overall will be presented. Baseline is the last value recorded prior to start of study treatment from AMB112529. Change from Baseline is calculated by subtracting the Baseline value from the end of study post-dose visit value. Data for this endpoint will be available for this endpoint by June 2023 |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Estriol at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | Estriol level of female participants will be measured. Only those parameters having status as overall will be presented. Baseline is the last value recorded prior to start of study treatment from AMB112529.Change from Baseline is calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. Data for this endpoint will be available for this endpoint by June 2023 |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Estradiol at End of Study | Baseline (Day 1) and up to 10 years and 11 months | Estradiol level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Female: Estradiol at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | Estradiol level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Male: FSH and LH at End of Study | Baseline (Day 1) and up to 10 years and 11 months | FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Male: FSH and LH at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Male: Inhibin B at End of Study | Baseline (Day 1) and up to 10 years and 11 months | Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Plasma Endocrine Parameters - Male: Inhibin B at 20 Years of Age of Participants | Baseline (Day 1) and at 20 years of age of participants | Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01342952/registered?page=2