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See termination reason in detailed description.
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PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF03882845 | Experimental |
| |
| Spironolactone | Active Comparator | 25 mg once daily |
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| Placebo | Placebo Comparator | Placebo once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03882845 | Drug | 3 mg tablet once daily |
| |
| PF-03882845 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Chula Vista | California | 91911 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Total 6 participants were enrolled in the study. Study was terminated early after partial completion of Cohort 1 (PF-03882845 3 milligram (mg)/placebo) and Cohort 4 (spironolactone 25 mg/placebo); Cohort 2 (PF-03882845 1 or 10 mg/placebo) and Cohort 3 (PF-03882845 1, 10 or 30 mg/placebo) were not enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03882845 Placebo | Placebo matched to PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14. |
| FG001 | PF-03882845 3 mg | PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Randomization |
|
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| Drug |
up to 10 mg tablet once daily |
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| PF-03882845 | Drug | up to 30 mg once daily |
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| Spironolactone | Drug | spironolactone 25 mg once daily |
|
| placebo | Other | placebo once daily |
|
| 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 |
| 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 |
| FG002 | Spironolactone Placebo | Similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14. |
| COMPLETED |
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| NOT COMPLETED |
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| Re-randomization |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All participants who were enrolled in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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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 | 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Median | Full Range | milliequivalent/liter (mEq/L) | Baseline, Day 7, 8 |
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| Primary | 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Median | Full Range | mEq/L | Baseline, Day 14, 15 |
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| Primary | 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Day 15 |
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| 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. | Data for all pre-specified PK parameters were not analyzed because a decision was made to prematurely terminate the study. | Posted | 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14 |
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| Secondary | 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Day 1 (Baseline), 15 |
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| Secondary | 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Day 1 (Baseline), 15 |
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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 | Placebo | Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14. | 0 | 4 | 1 | 4 | ||
| EG001 | PF-03882845 3 mg | PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14. | 0 | 5 | 2 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site injury | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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Study was terminated prematurely; this was based on a strategic decision by the sponsor to terminate further development of this compound for proposed indication. The study was not terminated for safety or lack of efficacy reasons.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C552104 | (3S,3aR)-2-(3-chloro-4-cyanophenyl)-3-cyclopentyl-3,3a,4,5-tetrahydro-2H-benzo(g)indazole-7-carboxylic acid |
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
|
| greater than or equal to (>=) 65 years |
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