Trial · NCT00568178
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
NCT00568178, Phase 3, Completed, Organon and Co; results first posted 2009-10-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2)). Trials, record NCT00568178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00568178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
- NCT number
- NCT00568178
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 306 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Proteinuria
- Interventions
- Losartan Potassium, Comparator: Placebo (Losartan), Comparator: amlodipine besylate, Comparator: Placebo (amlodipine besylate), Placebo (Losartan), Enalapril Maleate
- First posted
- 2007-12-05
- Last updated
- 2024-05-23
- Other registries' IDs
- eudract:2006-006415-74
- Results first posted
- 2009-10-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 | Baseline and 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. |
| Primary | Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 | Baseline and 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. |
| Primary | Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 | Baseline and 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. |
| Secondary | Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 | Baseline and Week 12 | |
| Secondary | Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 | Baseline and Week 12 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 | Baseline and Week 12 | Full Analysis Set included all randomized participants who took at least one dose of study drug and had baseline and post randomization measurements available | Percent Change in Pr/Cr | GEOMETRIC_MEAN |
| SECONDARY | Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 | Baseline and 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. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 | Baseline and 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 | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 | Baseline and Month 36 | 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. | Percent Change in Pr/Cr | GEOMETRIC_MEAN |
| PRIMARY | Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 | Baseline and Month 36 | 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. | Change in GFR mL/min1.73m^2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 | Losartan | -35.80 | 95% Confidence Interval -43.11 to -27.55 | Percent Change in Pr/Cr | |
| Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 | Amlodipine/Placebo | 1.37 | 95% Confidence Interval -10.27 to 14.51 | Percent Change in Pr/Cr | |
| Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 | Losartan-Hypertensive Participants | -5.5 | 95% Confidence Interval -8.6 to -2.4 | mm Hg | |
| Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 | Amlodipine-Hypertensive Participants | -0.1 | 95% Confidence Interval -3.3 to 3.1 | mm Hg | |
| Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 | Losartan-Hypertensive Participants | -3.8 | 95% Confidence Interval -7.0 to -0.7 | mm Hg | |
| Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 | Amlodipine-Hypertensive Participants | 0.8 | 95% Confidence Interval -2.5 to 4.1 | mm Hg | |
| Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 | Losartan Open Label Extension | -30.01 | 95% Confidence Interval 5.02 | Percent Change in Pr/Cr | |
| Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 | Enalapril Open Label Extension | -40.45 | 95% Confidence Interval 2.10 | Percent Change in Pr/Cr | |
| Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 | Losartan Open Label Extension | 3.3 | 95% Confidence Interval 66.3 | Change in GFR mL/min1.73m^2 | |
| Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 | Enalapril Open Label Extension | 7.0 | 95% Confidence Interval 53.2 | Change in GFR mL/min1.73m^2 |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Base Study | STARTED | Losartan Double Blind Normortensive | 122 | |
| Double Blind Base Study | STARTED | Placebo Double Blind Normotensive | 124 | |
| Double Blind Base Study | STARTED | Losartan Double Blind Hypertensive | 30 | |
| Double Blind Base Study | STARTED | Amlodipine Double Blind Hypertensive | 30 | |
| Double Blind Base Study | STARTED | Losartan Open Label Extension | 0 | |
| Double Blind Base Study | STARTED | Enalapril Open Label Extension | 0 | |
| Double Blind Base Study | COMPLETED | Losartan Double Blind Normortensive | 116 | |
| Double Blind Base Study | COMPLETED | Placebo Double Blind Normotensive | 118 | |
| Double Blind Base Study | COMPLETED | Losartan Double Blind Hypertensive | 29 | |
| Double Blind Base Study | COMPLETED | Amlodipine Double Blind Hypertensive | 25 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events352
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Losartan: Double-Blind Base Study | 0 | 152 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Amlodipine/Placebo: Double-Blind Base Study | 0 | 154 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Losartan Open-Label Extension | 11 | 134 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Enalapril: Open-Label Extension | 8 | 134 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Losartan: Double-Blind Base Study | 8 | 152 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Amlodipine/Placebo: Double-Blind Base Study | 7 | 154 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Losartan Open-Label Extension | 12 | 134 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Enalapril: Open-Label Extension | 7 | 134 | 9 |
| other | Vomiting | Gastrointestinal disorders | Losartan: Double-Blind Base Study | 6 | 152 | 8 |
| other | Vomiting | Gastrointestinal disorders | Amlodipine/Placebo: Double-Blind Base Study | 4 | 154 | 4 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan: Double-Blind Base Study | ||
| Total, all-cause mortality | Amlodipine/Placebo: Double-Blind Base Study | ||
| Total, all-cause mortality | Losartan Open-Label Extension | ||
| Total, all-cause mortality | Enalapril: Open-Label Extension | ||
| Total, other adverse events | Losartan: Double-Blind Base Study | 71 | 152 |
| Total, other adverse events | Amlodipine/Placebo: Double-Blind Base Study | 66 | 154 |
| Total, other adverse events | Losartan Open-Label Extension | 83 | 134 |
| Total, other adverse events | Enalapril: Open-Label Extension | 78 | 134 |
| Total, serious adverse events | Losartan: Double-Blind Base Study | 8 | 152 |
| Total, serious adverse events | Amlodipine/Placebo: Double-Blind Base Study | 5 | 154 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00568178
GET https://conductscience.org/api/trials/v1/NCT00568178/flow?page=2