Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents
NCT ID: NCT01939496
Last Updated: 2017-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
171 participants
INTERVENTIONAL
2013-10-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Placebo
Each patient will receive matching placebo once daily for 6 weeks.
Placebo
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Interventions
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Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Placebo
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Eligibility Criteria
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Inclusion Criteria
* patients with hypertension (seated office SBP of \>=130 mmHg and \<160 mmHg and seated office DBP of \>= 70 mmHg at screening and at Week -2
* patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
* patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening
Exclusion Criteria
* type 1 diabetes mellitus (T1DM)
* pancreas or beta-cell transplantation
* fasting C-peptide \<0.70 ng/mL (0.23 nmol/L)
* body mass index \<30 kg/m2
* has ongoing, inadequately controlled thyroid disorder
* has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
18 Years
75 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Birmingham, Alabama, United States
Gulf Shores, Alabama, United States
Avondale, Arizona, United States
Phoenix, Arizona, United States
Glendale, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Pismo Beach, California, United States
Rancho Cucamonga, California, United States
Roseville, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Tustin, California, United States
Denver, Colorado, United States
Brandon, Florida, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Lake Worth, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
West Palm Beach, Florida, United States
Perry, Georgia, United States
Rincon, Georgia, United States
Indianapolis, Indiana, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Mandeville, Louisiana, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
Auburn, Maine, United States
Elkridge, Maryland, United States
Dearborn, Michigan, United States
Kalamazoo, Michigan, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Morganville, New Jersey, United States
Whiting, New Jersey, United States
Albuquerque, New Mexico, United States
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
Altoona, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Sugar Land, Texas, United States
Salt Lake City, Utah, United States
Renton, Washington, United States
Carolina, , Puerto Rico
Ponce Pr, , Puerto Rico
Trujillo Alto, , Puerto Rico
Countries
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References
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Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.
Other Identifiers
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28431754DIA4002
Identifier Type: OTHER
Identifier Source: secondary_id
CR102208
Identifier Type: -
Identifier Source: org_study_id
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