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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006415-74 | EudraCT Number |
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The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
The study included a 12-week double-blind treatment phase and a 36-month open-label extension phase. Participants who completed or discontinued the initial 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. The open label extension was designed to continue until the 100th participant completed 3 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan Double-Blind Base Study (12-weeks) | Experimental | Normotensive participants received losartan. Hypertensive participants received either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo). |
|
| Amlodipine Double-Blind Base Study (12-weeks) | Active Comparator | Hypertensive participants were randomized to receive either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo) for 12 weeks. |
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| Losartan Open-Label Extension Phase (Month 36) | Experimental | Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient). |
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| Enalapril Open-Label Extension Phase (Month 36) | Active Comparator | Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan Potassium | Drug | Losartan Use During the Double-Blind Treatment Phase: Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed <50 kg) or 100 mg/day (if the patient weighed ≥50 kg). Losartan Use During the Treatment Extension Phase: Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 | Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment. Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period. | Baseline and Week 12 |
| Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 | Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment. *The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase. | Baseline and Month 36 |
| Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 | The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula: GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL) GFR values were compared to the baseline GFR measure. [Note: For male participants, ages 13 to 17 years, 0.70 was used as the multiplier in place of 0.55] Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase. | Baseline and Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 | Baseline and Week 12 | |
| Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23207876 | Derived | Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, McCrary Sisk C, Lam C. Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. Pediatr Nephrol. 2013 May;28(5):737-43. doi: 10.1007/s00467-012-2372-9. Epub 2012 Dec 4. | |
| 22739977 | Derived | Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, Santoro EP, Sisk CM, Lam C. Losartan and enalapril are comparable in reducing proteinuria in children. Kidney Int. 2012 Oct;82(7):819-26. doi: 10.1038/ki.2012.210. Epub 2012 Jun 27. |
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During a 4-week, single-blind run-in participants received losartan placebo (normotensive) or amlodipine (hypertensive) and underwent wash-out of anti-hypertensive agents. To qualify for randomization, participants had to have a mean urine Pr/Cr ratio of ≥0.3 gram/gram (gm/gm) derived from baseline urine samples.
As of March 2011, the study was completed.
Phase III First Patient In: 21Jun07; Last Patient Last Visit (double-blind base study): 16Sep08; and (open-label extension): 31Mar11. The study included 52 centers (USA, Europe, Latin America, and Asia) and participants included children aged 6-17 (hypertensive) or 1-17 (normotensive) with proteinuria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan Double Blind Normortensive | Normotensive participants who were randomized to losartan. Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks; or losartan placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Base Study |
|
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| Comparator: Placebo (Losartan) | Other | Placebo (losartan suspension), administered orally, once daily for 12 weeks |
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| Comparator: amlodipine besylate | Drug | Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks |
|
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| Comparator: Placebo (amlodipine besylate) | Other | Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks |
|
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| Placebo (Losartan) | Other | Normotensive patients randomized to losartan placebo for 12 weeks. |
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| Enalapril Maleate | Drug | Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months. |
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| Baseline and Week 12 |
| 21285125 | Derived | Webb NJ, Lam C, Shahinfar S, Strehlau J, Wells TG, Gleim GW, Le Bailly De Tilleghem C. Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. Nephrol Dial Transplant. 2011 Aug;26(8):2521-6. doi: 10.1093/ndt/gfq797. Epub 2011 Feb 1. |
| FG001 | Placebo Double Blind Normotensive | Normotensive participants who were randomized to losartan placebo. Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks. |
| FG002 | Losartan Double Blind Hypertensive | Hypertensive patients who were randomized to receive losartan and amlodipine placebo for 12 weeks. Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study. Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks. |
| FG003 | Amlodipine Double Blind Hypertensive | Hypertensive patients who were randomized to receive amlodipine and losartan placebo for 12 weeks. Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks. |
| FG004 | Losartan Open Label Extension | Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril. Dosing of study medication during the extension phase of the study was at the investigator's discretion. Losartan 25-mg and 50-mg tablets were available for patients able to swallow tablets. For patients unable to swallow tablets, or who weighed <25 kg, losartan suspension (2.5 mg/ml) was prepared. |
| FG005 | Enalapril Open Label Extension | Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril. Dosing of study medication during the extension phase of the study was at the investigator's discretion. Enalapril 2.5-, 5-, 10-, and 20-mg tablets were available for participants able to swallow tablets. For participants unable to swallow tablets, or who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. |
| COMPLETED |
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| NOT COMPLETED |
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| Open Label Extension |
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo). "Losartan" group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo. Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study. Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks. |
| BG001 | Amlodipine/Placebo | "Amlodipine/Placebo" group includes the following: Normotensive patients randomized to losartan. Hypertensive patients randomized to amlodipine and losartan placebo. Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Hypertensive | Sitting systolic blood pressure (SiSBP) or diastolic blood pressure (SiDBP) ≥90th percentile AND participant on medication for proteinuria/hypertension OR SiSBP or SiDBP ≥95th percentile AND participant NOT on medication for proteinuria/hypertension OR documented hypertension and on anti-hypertensive medication, whether or not medicated for proteinuria. | Number | Participants |
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| Prior Angiotensin Converting Enzyme Inhibitor /Angiotensin II Type I Receptor Blocker (ACE-I/ARB)Use | Number | Participants |
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| Race | Number | participants |
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| Region | Number | Participants |
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| Tanner Stage | A scale of physical development. The scale defines physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Stages range from I to V with I being the least developed. | Number | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared (kg/m2) |
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| Duration of Hypertension | Mean | Standard Deviation | Years |
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| Height | Mean | Standard Deviation | Centimeters (cm) |
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| Protein-to-Creatinine Ratio | Mean | Standard Deviation | grams/grams |
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| Sitting Diastolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury (mm Hg) |
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| Sitting Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Weight | Mean | Standard Deviation | Kilograms (kg) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 | Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment. Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period. | Full Analysis Set included all randomized participants who took at least one dose of study drug and had baseline and post randomization measurements available | Posted | Geometric Mean | 95% Confidence Interval | Percent Change in Pr/Cr | Baseline and Week 12 |
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| Secondary | Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 | All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Baseline and Week 12 |
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| Secondary | Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 | All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Baseline and Week 12 |
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| Primary | Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 | Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment. *The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase. | Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only the individuals who satisfied the criteria. | Posted | Geometric Mean | 95% Confidence Interval | Percent Change in Pr/Cr | Baseline and Month 36 |
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| Primary | Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 | The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula: GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL) GFR values were compared to the baseline GFR measure. [Note: For male participants, ages 13 to 17 years, 0.70 was used as the multiplier in place of 0.55] Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase. | Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only individuals who satisfied the criteria. | Posted | Least Squares Mean | 95% Confidence Interval | Change in GFR mL/min1.73m^2 | Baseline and Month 36 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan: Double-Blind Base Study | Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo). "Losartan" group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo. Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study. Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks. | 8 | 152 | 71 | 152 | ||
| EG001 | Amlodipine/Placebo: Double-Blind Base Study | "Amlodipine/Placebo" group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo. Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks. | 5 | 154 | 66 | 154 | ||
| EG002 | Losartan Open-Label Extension | Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment. Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum dose of losartan was 50 mg/day (if the participant weighed <50 kg) or 100 mg/day (if the participant weighed ≥50 kg) Losartan 25-mg and 50-mg tablets were available for participants able to swallow tablets, and losartan suspension (2.5 mg/ml) was prepared for participants unable to swallow tablets, or for those who weighed <25 kg. | 27 | 134 | 83 | 134 | ||
| EG003 | Enalapril: Open-Label Extension | Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment. Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum specified dose of enalapril was 40 mg/day. For participants unable to swallow tablets, or for those who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. The starting dose of drug and any adjustments during the open-label period were at the discretion of the investigator. | 25 | 134 | 78 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lipomeningocele | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal hypoplasia | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Somatoform disorder neurologic | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urine protein/creatinine ratio increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019808 | Losartan |
| D017311 | Amlodipine |
| D004656 | Enalapril |
| D015773 | Enalaprilat |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Protocol Violation |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Progressive Disease |
|
| Termination of Trial |
|
| Withdrawal by Subject |
|
| 7-12 Years of Age |
|
| 13-17 Years of Age |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| No |
|
| No |
|
| Black |
|
| Multi-Racial |
|
| White |
|
| Other |
|
| Outside of United States |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Stage V |
|
|
|
|
|
|
|
|
All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
|
|
|