| Trial ID: | L0218 |
| Source ID: | NCT00810732
|
| Associated Drug: |
Open
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| Title: |
Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
|
| Acronym: |
FCRD01
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00810732/results
|
| Conditions: |
Chronic Kidney Disease
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| Interventions: |
DRUG: Open|DRUG: Nifedipine|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6, Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period., Baseline, Week 6 | Secondary: Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6, The 24-hour ambulatory BP monitoring was performed by using a BP cuff which was attached to the participant's arm, using the same arm throughout the study, with a small monitor that comfortably sits in the pocket of participant. Mean values over 24-hour measurements at each measurement period were calculated. The change in total 24-hour ambulatory monitoring of systemic arterial BP, SBP and DBP at Week 3 and 6 relative to baseline were reported. Baseline was as an average of the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period., Baseline, Week 3 and 6|Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6, Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Baseline was defined as the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period., Baseline, Week 3 and 6
|
| Sponsor/Collaborators: |
Sponsor: Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-05-09
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| Completion Date: |
2009-03-06
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| Results First Posted: |
2023-07-06
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| Last Update Posted: |
2023-07-06
|
| Locations: |
Clinical Research Centre and Pharmacology Unit, Edinburgh, Scotland, EH4 2XU, United Kingdom|the University of Edinburgh, Western General Hospital, Department of Medical Sciences, Edinburgh, Scotland, EH4 2XU, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00810732
|
