A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200394
First received: September 10, 2010
Last updated: May 19, 2014
Last verified: May 2014
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Purpose
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Nephropathies |
Drug: PF-00489791 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Evaluate The Efficacy And Safety Of Once-Daily Administration Of A Phosphodiesterase 5 Inhibitor (PF-00489791) In Adults With Type 2 Diabetes And Overt Nephropathy |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Urine albumin: creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urine albumin: creatinine ratio at 3, 6 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Urine protein: creatinine ratio at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Estimated glomerular filtration rate at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Serum creatinine at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Urinary TGFbeta1 at Weeks 3, 6, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Serum C-reactive protein (hs-CRP) at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Serum cystatin C at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- An assessment of the pharmacokinetic parameters of PF-00489791. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Plasma glycosylated hemoglobin (HbA1c). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 256 |
| Study Start Date: | October 2010 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-00489791 |
Drug: PF-00489791
Tablet, 20 mg once daily for 12 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Tablet, placebo once daily for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
- Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
Exclusion Criteria:
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
- Subjects on combination ACE inhibitor/ARB therapy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394
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Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35805 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Glendale, Arizona, United States, 85306 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85004 | |
| Pfizer Investigational Site | |
| Tempe, Arizona, United States, 85284 | |
| United States, California | |
| Pfizer Investigational Site | |
| Azusa, California, United States, 91702 | |
| Pfizer Investigational Site | |
| Covina, California, United States, 91723 | |
| Pfizer Investigational Site | |
| La Mesa, California, United States, 91942 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95825 | |
| Pfizer Investigational Site | |
| San Dimas, California, United States, 91773 | |
| Pfizer Investigational Site | |
| Whittier, California, United States, 90602 | |
| Pfizer Investigational Site | |
| Yuba, California, United States, 95991 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Edgewater, Florida, United States, 32132 | |
| Pfizer Investigational Site | |
| Hialeah, Florida, United States, 33012 | |
| Pfizer Investigational Site | |
| Jupiter, Florida, United States, 33458 | |
| Pfizer Investigational Site | |
| Summerfield, Florida, United States, 34491 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Conyers, Georgia, United States, 30094 | |
| Pfizer Investigational Site | |
| Macon, Georgia, United States, 31217 | |
| United States, Idaho | |
| Pfizer Investigational Site | |
| Meridian, Idaho, United States, 83642 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60616 | |
| Pfizer Investigational Site | |
| Evergreen Park, Illinois, United States, 60805 | |
| Pfizer Investigational Site | |
| Peoria, Illinois, United States, 61603 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Elwood, Indiana, United States, 46036 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Metairie, Louisiana, United States, 70006 | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Rockville, Maryland, United States, 20852 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Dearborn, Michigan, United States, 48124 | |
| Pfizer Investigational Site | |
| Flint, Michigan, United States, 48504 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64111-5964 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89101 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Ashville, North Carolina, United States, 28801 | |
| Pfizer Investigational Site | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Willoughby Hills, Ohio, United States, 44094 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Pfizer Investigational Site | |
| Uniontown, Pennsylvania, United States, 15401 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Bamberg, South Carolina, United States, 29003 | |
| Pfizer Investigational Site | |
| Columbia, South Carolina, United States, 29203 | |
| Pfizer Investigational Site | |
| Greenville, South Carolina, United States, 29605 | |
| Pfizer Investigational Site | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78751 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77054 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77004 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78215 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Fairfax, Virginia, United States, 22033 | |
| Pfizer Investigational Site | |
| Mechanicsville, Virginia, United States, 23116 | |
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| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Bremerton, Washington, United States, 98310 | |
| Pfizer Investigational Site | |
| PortOrchard, Washington, United States, 98366 | |
| Pfizer Investigational Site | |
| Silverdale, Washington, United States, 98383 | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Gosford, New South Wales, Australia, 2250 | |
| Pfizer Investigational Site | |
| Newcastle, New South Wales, Australia, 2305 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Reservoir, Victoria, Australia, 3073 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2R 0X7 | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Brampton, Ontario, Canada, L6Z 4N5 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 5A5 | |
| Pfizer Investigational Site | |
| Oakville, Ontario, Canada, L6J 3M5 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M4C 5T2 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3M 3E3 | |
| Canada, Saskatchewan | |
| Pfizer Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7M 2Z1 | |
| Denmark | |
| Pfizer Investigational Site | |
| Aarhus C, Denmark, DK-8000 | |
| Pfizer Investigational Site | |
| Copenhagen Oe, Denmark, 2100 | |
| Pfizer Investigational Site | |
| Gentofte, Denmark, 2820 | |
| Hong Kong | |
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| Hong Kong, Hong Kong | |
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| Pokfulam, Hong Kong | |
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| Quarry Bay, Hong Kong | |
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| Shatin, Hong Kong, N.T. 0 | |
| India | |
| Pfizer Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500096 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 013 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 007 | |
| Pfizer Investigational Site | |
| Mumbai, Maharashtra, India, 400016 | |
| Pfizer Investigational Site | |
| Mumbai, Maharashtra, India, 400102 | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411 001 | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411 011 | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411 004 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 | |
| Pfizer Investigational Site | |
| Seongnam-si, Korea, Republic of, 463-707 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 156-707 | |
| Malaysia | |
| Pfizer Investigational Site | |
| Kota Bharu, Kelantan, Malaysia, 16150 | |
| Pfizer Investigational Site | |
| Kubang Kerian, Kelantan, Malaysia, 16150, | |
| Pfizer Investigational Site | |
| Taiping, Perak, Malaysia, 34000 | |
| Pfizer Investigational Site | |
| George Town, Pulau Pinang, Malaysia, 10990 | |
| Pfizer Investigational Site | |
| Kota Kinabalu, Sabah, Malaysia, 88586 | |
| Pfizer Investigational Site | |
| Kajang, Selangor, Malaysia, 43000 | |
| Mexico | |
| Pfizer Investigational Site | |
| Angeles del Pedregal Cp., D.f., Mexico, 10700 | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 06100 | |
| Pfizer Investigational Site | |
| Guadalajara, Jalisco, Mexico, 44600 | |
| Pfizer Investigational Site | |
| Tlalpan, Mexico City, Mexico, 14000 | |
| Pfizer Investigational Site | |
| San Luis Potosi, San Luis, Mexico, 78240 | |
| Poland | |
| Pfizer Investigational Site | |
| Bielsko-Biala, Poland, 43-300 | |
| Pfizer Investigational Site | |
| Katowice, Poland, 40-027 | |
| Pfizer Investigational Site | |
| Lublin, Poland, 20-536 | |
| Pfizer Investigational Site | |
| Warsaw, Poland, 4749 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 02-256 | |
| Pfizer Investigational Site | |
| Wroclaw, Poland, 50-556 | |
| Serbia | |
| Pfizer Investigational Site | |
| Belgrade, Serbia, 11 000 | |
| Pfizer Investigational Site | |
| Belgrade, Serbia, 11000 | |
| Pfizer Investigational Site | |
| Nis, Serbia, 18000 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 813 69 | |
| Pfizer Investigational Site | |
| Levice, Slovakia, 934 01 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 081 81 | |
| Pfizer Investigational Site | |
| Rimavska Sobota, Slovakia, 979 12 | |
| South Africa | |
| Pfizer Investigational Site | |
| Benoni, Gauteng, South Africa, 1500 | |
| Pfizer Investigational Site | |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0204 | |
| Pfizer Investigational Site | |
| Durban, KwaZulu Natal, South Africa, 4091 | |
| Pfizer Investigational Site | |
| Bloemfontein, South Africa, 9301 | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7925 | |
| Pfizer Investigational Site | |
| Durban, South Africa, 4001 | |
| Pfizer Investigational Site | |
| Houghton, Johannesburg, South Africa, 2198 | |
| Pfizer Investigational Site | |
| Parow, South Africa, 7500 | |
| Pfizer Investigational Site | |
| Pretoria, South Africa, 132 | |
| Sweden | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 413 45 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 111 57 | |
| Pfizer Investigational Site | |
| Uppsala, Sweden, 751 85 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Doncaster, South Yorkshire, United Kingdom, DN2 5LT | |
| Pfizer Investigational Site | |
| Coventry, United Kingdom, CV2 2DX | |
| Pfizer Investigational Site | |
| Edinburgh, United Kingdom, EH16 4TJ | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| Pfizer Investigational Site | |
| London, United Kingdom, E1 1BB | |
| Pfizer Investigational Site | |
| Sheffield, United Kingdom, S5 7AU | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01200394 History of Changes |
| Other Study ID Numbers: | A7331011 |
| Study First Received: | September 10, 2010 |
| Last Updated: | May 19, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Diabetic nephropathy chronic kidney disease PF-00489791 phosphodiesterase PDE5 |
Additional relevant MeSH terms:
|
Diabetic Nephropathies Kidney Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015