Trial · NCT00413777
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion. | AEs were recorded from screening (ICF was signed) until 7-Day follow-up | Safety dataset was defined as all participants who consumed at least 1 dose of study medication. Safety variables analyzed included physical examinations, laboratory tests, vital signs, ECG's and AEs. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose. | Baseline to Month 36 | The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used. | mOsm/kg | MEAN |
| SECONDARY | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose. | Baseline to Month 24 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mOsm/kg | MEAN |
| SECONDARY | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime. | Baseline to Month 24 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mOsm/kg | MEAN |
| SECONDARY | Percent Change From Baseline in Renal Volume. | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | Percentage change per month | MEAN |
| SECONDARY | Change From Pre-dose Baseline in Renal Function Estimated by Glomerular Filtration Rate (GFR). | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | dL/mg | MEAN |
| SECONDARY | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose- Extension. | Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12 | The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used. | mOsm/kg | MEAN |
| SECONDARY | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose- Extension. | Baseline to Month 24 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mOsm/kg | MEAN |
| SECONDARY | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime- Extension. | Baseline to Month 24 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mOsm/kg | MEAN |
| SECONDARY | Percent Change From Baseline in Renal Volume-Extension. | Baseline to Months 2, 12, 24, 36, Extension Day 1, Extension Month 12 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | Percentage change per month | MEAN |
| SECONDARY | Change From Pre-dose Baseline in Renal Function Estimated by GFR- Extension. | Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 12 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | dL/mg | MEAN |
| SECONDARY | Mean Change From Baseline in Systolic Blood Pressure (sBP) for Hypertension Assessment. | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in Diastolic Blood Pressure (dBP) for Hypertension Assessment. | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in Mean Arterial Pressure (MAP) for Hypertension Assessment. | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in sBP for Hypertension Assessment- Extension. | Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in dBP for Hypertension Assessment- Extension. | Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in MAP for Hypertension Assessment- Extension. | Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in Patient-assessed Renal Pain Scale. | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Patient-assessed Renal Pain Scale- Extension. | Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Abdominal Girth Measurement. | Baseline to Month 36 | The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used. | cm | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00413777/outcomes