None listed
Conditions
Interventions
SUBJECTS WILL ALSO BE ON A STABLE EFFECTIVE THERAPEUTIC DOSE OF AN ANGIOTENSIN-CONVERTING ENZYME INHIBITOR (ACEI) OR AN ANGIOTENSIN RECEPTOR BLOCKER (ARB) FOR AT LEAST 4 WEEKS PRIOR TO ENROLLMENT.
10.0% EVALUATED AT THE ENROLLMENT VISIT BY THE CENTRAL LABORATORY.
• INADEQUATELY CONTROLLED HYPERTENSION: SEATED SYSTOLIC BP (SBP) ≥
140 AND <165 mmHG AND SEATED DIASTOLIC BP (DBP) ≥
85 AND <105 mmHG, EACH REPRESENTING THE MEAN OF THREE DETERMINATIONS, EVALUATED AT THE ENROLLMENT AND DAY 1 VISITS AND 24-HOUR MEAN BLOOD PRESSURE OF ≥
130/80 AS DETERMINED BY AMBULATORY BLOOD PRESSURE MONITORING (ABPM) MEASURED BETWEEN DAY-7 AND DAY-1, WITHIN 1 WEEK PRIOR TO THE DAY 1 RANDOMIZATION VISIT.
SUBJECTS WILL BE ELIGIBLE FOR A RANDOMIZ
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 89 Years
Inclusion criteria
Inclusion criteria: SIGNED WRITTEN INFORMED CONSENT 1) SUBJECTS MUST BE WILLING AND ABLE TO GIVE SIGNED AND DATED WRITTEN INFORMED CONSENT. TARGET POPULATION 2) SUBJECTS MUST HAVE TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL, DEFINED AS CENTRAL LABORATORY HbA1c ≥ 7.0% and ≤ 10.0% OBTAINED AT THE ENROLLMENT VISIT. NOTE: A ONE-TIME CENTRAL LABORATORY RE-TEST OF THE HBA1C TEST IS ALLOWED IN SUBJECTS WITH AN INITIAL CENTRAL LABORATRY HbA1c OF 6.9% OR 10.1% WHO ARE OTHERWISE ELIGIBLE, AS DETERMINED BY THE INVESTIGATOR. 3) SUBJECTS MUST BE ON A STABLE DOSE OF AN OAD FOR AT LEAST 6 WEEKS (12 WEEKS FOR A TZD) PRIOR TO ENROLLMENT AND A STABLE EFFECTIVE THERAPEUTIC DOSE OF AN ACEI OR AN ARB FOR AT LEAST 4 WEEKS. STABLE DOSE IS DEFINED AS A DOSE THAT HAS REMAINED THE SAME FOR THE SPECIFIED NUMBER OF WEEKS, AS MENTIONED ABOVE, PRIOR TO THE ENROLLMENT VISIT (ie, SAME PRESCRIBED TOTAL DAILY DOSE). MINIMUM EFFECTIVE THERAPEUTIC DOSES OF ALL ACEI AND ARB ARE DEFINED IN APPENDIX 5. NOTE: SUBJECTS TREATED WITH MORE THAN ONE OAD (COMBINATION OAD MEDICATIONS) WILL BE ALLOWED AS LONG AS THE DOSES OF THE COMBINATION OAD MEDICATIONS HAVE BEEN STABLE FOR THE SPECIFIED NUMBER OF WEEKS.
Exclusion criteria
Exclusion criteria: TARGET DISEASE EXCEPTIONS 1) HISTORY OF DIABETES INSIPIDUS. 2) SYMPTOMS OF POORLY CONTROLLED DIABETES THAT WOULD PRECLUDE PARTICIPATION IN THIS TRIAL INCLUDING, BUT NOT LIMITED TO, MARKED POLYURIA AND POLYDIPSIA WITH GREATER THAN 10% WEIGHT LOSS DURING THE 3 MONTHS PRIOR TO ENROLLMENT, OR OTHER SIGNS AND SYMPTOMS. 3) HISTORY OF DIABETIC KETOACIDOSIS OR HYPEROSMOLAR NONKETOTIC COMA. MEDICAL HISTORY AND CONCURRENT DISEASES CV/VASCULAR DISEASES: 4) HISTORY OF MALIGNANT OR ACCELERATED HYPERTENSION. 5) KNOWN OR SUSPECTED SECONDARY HYPERTENSION. ANY OF THE FOLLOWING CV/VASCULAR DISEASES WITHIN 6 MONTHS OF THE ENROLLMENT VISIT: 6) MYOCARDIAL INFARCTION. 7) CARDIAC SURGERY OR REVASCULARIZATION (CORONARY ARTERY BYPASS SURGERY [CABG] / PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY [PTCA]). 8) UNSTABLE ANGINA. 9) UNSTABLE CONGESTIVE HEART FAILURE (CHF). 10) CHF NEW YORK HEART ASSOCIATION (NYHA) CLASS III OR IV. (SEE APPENDIX 1) 11) TRANSIENT ISCHEMIC ATTACK (TIA) OR SIGNIFICANT CEREBROVASCULAR DISEASE. 12) UNSTABLE OR PREVIOUSLY UNDIAGNOSED ARRHYTHMIA.
Countries
Canada, Colombia, Czech Republic, Denmark, Finland, Germany, Hungary, India, Mexico, Peru, Poland, Romania, Russian Federation, Spain, United States
Contacts
Public ContactCristina Eyzaguirre
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed