Trial · NCT00413777
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in a study , whether or not it was considered drug-related by the study physician. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study drug treatment; or if the event was continuous from Baseline and was serious, study drug related, or resulted in death, discontinuation. |
| Secondary | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose. | Baseline to Month 36 | Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36 for all participants. Sample was taken after the first morning's void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting. |
| Secondary | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose. | Baseline to Month 24 | Urine osmolality at steady state (after at least 4 days of dosing) including "absolute trough" prior to the second daily dose. Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. |
| Secondary | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime. | Baseline to Month 24 | Urine osmolality at steady state (after at least 4 days of dosing) including "average of troughs" (the mean urine osmolality prior to bedtime). Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. |
| Secondary | Percent Change From Baseline in Renal Volume. | Baseline to Month 36 | Total Kidney Volume (TKV) was assessed by the central magnetic resonance imaging (MRI) rater. |
| Secondary | Change From Pre-dose Baseline in Renal Function Estimated by Glomerular Filtration Rate (GFR). | Baseline to Month 36 | GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration \[mg/dL\]). Clinic weight scales were calibrated at least yearly. |
| 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 | Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36, Extension Day 1, and Extension Month 12 for all participants. Sample was taken after the first morning's void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting. |
| Secondary | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose- Extension. | Baseline to Month 24 | Urine osmolality at steady state (after at least 4 days of dosing) including "absolute trough" prior to the second daily dose. Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. |
| Secondary | Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime- Extension. | Baseline to Month 24 | Urine osmolality at steady state (after at least 4 days of dosing) including "average of troughs" (the mean urine osmolality prior to bedtime). Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. |
| Secondary | Percent Change From Baseline in Renal Volume-Extension. | Baseline to Months 2, 12, 24, 36, Extension Day 1, Extension Month 12 | TKV was assessed by the central magnetic resonance imaging (MRI) rater. |
| 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 | GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration \[mg/dL\]). Clinic weight scales were calibrated at least yearly. |
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (sBP) for Hypertension Assessment. | Baseline to Month 36 | The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP \< 100 mm Hg and off therapy), high normal (sBP \> 129 and or dBP \> 84 mm Hg off therapy) or hypertensive (sBP \>140 and/or dBP \> 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + \[1/3 x pulse pressure (ie systolic - diastolic pressure)\] in mm Hg). |
| Secondary | Mean Change From Baseline in Diastolic Blood Pressure (dBP) for Hypertension Assessment. | Baseline to Month 36 | The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP \< 100 mm Hg and off therapy), high normal (sBP \> 129 and or dBP \> 84 mm Hg off therapy) or hypertensive (sBP \>140 and/or dBP \> 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + \[1/3 x pulse pressure (ie systolic - diastolic pressure)\] in mm Hg). |
| Secondary | Mean Change From Baseline in Mean Arterial Pressure (MAP) for Hypertension Assessment. | Baseline to Month 36 | The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP \< 100 mm Hg and off therapy), high normal (sBP \> 129 and or dBP \> 84 mm Hg off therapy) or hypertensive (sBP \>140 and/or dBP \> 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + \[1/3 x pulse pressure (ie systolic - diastolic pressure)\] in mm Hg). |
| 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 participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP \< 100 mm Hg and off therapy), high normal (sBP \> 129 and or dBP \> 84 mm Hg off therapy) or hypertensive (sBP \>140 and/or dBP \> 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + \[1/3 x pulse pressure (ie systolic - diastolic pressure)\] in mm Hg). |
| 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 participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP \< 100 mm Hg and off therapy), high normal (sBP \> 129 and or dBP \> 84 mm Hg off therapy) or hypertensive (sBP \>140 and/or dBP \> 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + \[1/3 x pulse pressure (ie systolic - diastolic pressure)\] in mm Hg). |
| 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 participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP \< 100 mm Hg and off therapy), high normal (sBP \> 129 and or dBP \> 84 mm Hg off therapy) or hypertensive (sBP \>140 and/or dBP \> 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + \[1/3 x pulse pressure (ie systolic - diastolic pressure)\] in mm Hg). |
| Secondary | Mean Change From Baseline in Patient-assessed Renal Pain Scale. | Baseline to Month 36 | Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, "On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months?" If the latest assessment was less than 4 months prior, the question was substituted "since your last visit" for "in the last 4 months". The same interrogator designated to this task was used throughout the study for each participant. |
| 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 | Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, "On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months?" If the latest assessment was less than 4 months prior, the question was substituted "since your last visit" for "in the last 4 months". The same interrogator designated to this task was used throughout the study for each participant. |
| Secondary | Mean Change From Baseline in Abdominal Girth Measurement. | Baseline to Month 36 | The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged). |
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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