Demostrar que la combinación a dosis fija de telmisartán y amlodipino es más eficaz en la reducción de la presión arterial.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure \>150 mmHg at Visit 3 (Randomisation visit)
Diagnosis of Type 2 diabetes mellitus
=18 years of age at the date of signing the informed consent
Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Ability to provide written informed consent

Criterios de exclusión

Pre-menopausal women (last menstruation \<=1 year prior to start of run-in period) who:
are not surgically sterile; and/or
are nursing or pregnant, or
are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study.
The only acceptable methods of birth control are:
Intrauterine device (IUD);
Oral contraceptives (started at least three months prior to start of run-in period)
Implantable or injectable contraceptives and
Estrogen patch
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)
Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods
Patients with Type 1 diabetes mellitus
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dL (or \>265 µmol /L) or known creatinine clearance \<30 mL/min or clinical markers of severe renal impairment
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
Clinically relevant hypokalaemia or hyperkalaemia
Uncorrected sodium or volume depletion
Primary aldosteronism
Hereditary fructose intolerance
Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency
Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)
Contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period)
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C \>10%
Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists
History of drug or alcohol dependency within six months prior to signing the informed consent form
Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Any investigational drug therapy within one month of signing the informed consent
Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
History of non-compliance or inability to comply with prescribed medications or protocol procedures
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine

Ubicaciones

1235.21.102 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1235.21.103 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1235.21.107 Boehringer Ingelheim Investigational Site

Ramos Mejía, Argentina

1235.21.101 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

1235.21.105 Boehringer Ingelheim Investigational Site

Zárate, Argentina

Estudio aleatorizado, doble ciego, de 8 semanas para comparar la combinación a dosis fija de telmisartán 80 + amlodipino 10 mg frente a la monoterapia con amlodipino 10 mg como tratamiento de primera línea en pacientes con diabetes tipo 2 e hipertensión

Resumen