Hypertension Clinical Trial
Official title:
A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
| Verified date | September 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.
| Status | Completed |
| Enrollment | 922 |
| Est. completion date | December 2012 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes mellitus. - Cardiovascular disease - Hypertension Exclusion Criteria: - Patients with type 1 diabetes or diabetes insipidus - Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes - Any clinically significant illness, which would compromise the patient's safety and their participation in the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | Caba |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Ciudad de Buenos Aires | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | La Plata | Buenos Aires |
| Argentina | Research Site | Mendoza | |
| Argentina | Research Site | Santa Fe | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Carbonear | Newfoundland and Labrador |
| Canada | Research Site | Courtice | Ontario |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Lachine | Quebec |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | Mississauga | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Mount Pearl | Newfoundland and Labrador |
| Canada | Research Site | New Westminster | British Columbia |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Saint-marc-des-carrieres | Quebec |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | Smiths Falls | Ontario |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Winnipeg | Manitoba |
| Germany | Research Site | Bad Nauheim | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Erdmannhausen | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Heilbronn | |
| Germany | Research Site | Hildesheim | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Munster | |
| Germany | Research Site | Potsdam | |
| Germany | Research Site | Potsdam | BR |
| Germany | Research Site | Speyer | |
| Germany | Research Site | Wahlstedt | |
| Romania | Research Site | Braila | |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Constanta | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Sibiu | |
| Romania | Research Site | Suceava | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Dolny Kubin | |
| Slovakia | Research Site | Komarno | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Kysucke Nove Mesto | |
| Slovakia | Research Site | Liptovsky Hradok | |
| Slovakia | Research Site | Lucenec | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Povazska Bystrica | |
| Slovakia | Research Site | Prievidza | |
| Slovakia | Research Site | Rimavska Sobota | |
| Slovakia | Research Site | Ruzomberok | |
| Slovakia | Research Site | Zilina | |
| Spain | Research Site | A Coruna | Galicia |
| Spain | Research Site | Barcelona | Cataluna |
| Spain | Research Site | Cordoba | Andalucia |
| Spain | Research Site | Granada | Andalucia |
| Spain | Research Site | Lerida | Cataluna |
| Spain | Research Site | Majadahonda | Comunidad de Madrid |
| Spain | Research Site | Olot (girona) | Cataluna |
| Spain | Research Site | Oviedo | Asturias |
| Spain | Research Site | Palma de Mallorca | Islas Baleares |
| Spain | Research Site | San Juan (alicante) | Comunidad Valenciana |
| Spain | Research Site | Santiago de Compostela | Galicia |
| Spain | Research Site | Sevilla | Andalucia |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Taiwan | Research Site | Changhua | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan County | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Tao-yuan | |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Brick | New Jersey |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Burbank | California |
| United States | Research Site | Carrollton | Texas |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Danville | Virginia |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | Deerfield Beach | Florida |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Garden Grove | California |
| United States | Research Site | Gulf Shores | Alabama |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Honolulu | Hawaii |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntington Park | California |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kingsport | Tennessee |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Lancaster | California |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Miami | Florida |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | North Richland Hills | Texas |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Oradell | New Jersey |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Phoenixville | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plano | Texas |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Port Orange | Florida |
| United States | Research Site | Reading | Pennsylvania |
| United States | Research Site | Salinas | California |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Marino | California |
| United States | Research Site | San Ramon | California |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | St Louis | Missouri |
| United States | Research Site | Stone Mountain | Georgia |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tomball | Texas |
| United States | Research Site | Tustin | California |
| United States | Research Site | Waterbury | Connecticut |
| United States | Research Site | West Monroe | Louisiana |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Winter Park | Florida |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Bristol-Myers Squibb |
United States, Vietnam, Argentina, Canada, Germany, Romania, Slovakia, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adjusted Mean Change in HbA1c Levels | To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24. | Baseline to Week 24 | No |
| Primary | Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit | To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure. | Baseline to week 24 | No |
| Secondary | Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) | To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo. | Baseline to Week 8 | No |
| Secondary | Adjusted Mean Percent Change in Body Weight | To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo. | Baseline to Week 24 | No |
| Secondary | Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF) | To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo. | Baseline to Week 24 | No |
| Secondary | Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI =27 kg/m² | To compare the proportion of participants with BMI baseline =27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum. | Baseline to Week 24 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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