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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 (Adult, Senior) |
| 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394
Hide Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394
Hide Study Locations
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, 64111-5964 | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| 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, 77004 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77054 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78215 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Fairfax, Virginia, United States, 22033 | |
| Pfizer Investigational Site | |
| Mechanicsville, Virginia, United States, 23116 | |
| Pfizer Investigational Site | |
| 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, T2N 2T9 | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2R 0X7 | |
| 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, H1T 2M4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3M 3E3 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| 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 | |
| Pfizer Investigational Site | |
| Hong Kong, Hong Kong | |
| Pfizer Investigational Site | |
| Pokfulam, Hong Kong | |
| Pfizer Investigational Site | |
| Quarry Bay, Hong Kong | |
| Pfizer Investigational Site | |
| Shatin, Hong Kong, N.T. 0 | |
| India | |
| Pfizer Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500096 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 007 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 013 | |
| 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, 411 004 | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411 011 | |
| 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, E1 1BB | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| 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:
| 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:
|
Kidney Diseases Diabetic Nephropathies Urologic Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016