| Trial ID: | L7135 |
| Source ID: | NCT01488877
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| Associated Drug: |
Pf-03882845
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| Title: |
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01488877/results
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| Conditions: |
Type 2 Diabetic Nephropathy
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| Interventions: |
DRUG: PF-03882845|DRUG: PF-03882845|DRUG: PF-03882845|DRUG: Spironolactone|OTHER: placebo
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| Outcome Measures: |
Primary: Change From Baseline in Serum Potassium at Day 8, Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8., Baseline, Day 7, 8|Change From Baseline in Serum Potassium at Day 15, Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15., Baseline, Day 14, 15|Number of Participants With Confirmed and Severe Hyperkalemia, Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (\>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level \>= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported., Baseline up to Day 15 | Secondary: Plasma Pharmacokinetic (PK) Parameters, PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed., 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14|Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15, Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements., Day 1 (Baseline), 15|Change From Baseline in Sitting Pulse Rate at Day 15, Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline., Day 1 (Baseline), 15
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| Sponsor/Collaborators: |
Sponsor: Pfizer
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
6
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2012-01
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| Completion Date: |
2012-07
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| Results First Posted: |
2013-09-23
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| Last Update Posted: |
2013-10-29
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| Locations: |
Pfizer Investigational Site, Chula Vista, California, 91911, United States|Pfizer Investigational Site, San Diego, California, 92123, United States|Pfizer Investigational Site, DeLand, Florida, 32720, United States|Pfizer Investigational Site, Miami, Florida, 33169, United States|Pfizer Investigational Site, Kalamazoo, Michigan, 49007, United States|Pfizer Investigational Site, New York, New York, 10019, United States
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| URL: |
https://clinicaltrials.gov/show/NCT01488877
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