Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Hypertension

In brief

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Key facts

Study ID

NCT00877929

Run by

Boehringer Ingelheim

People needed

706

Starts

2009-02-01

Last updated by the study team

2014-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• 1235.21.907 Boehringer Ingelheim Investigational Site — Tustin, California, United States
• 1235.21.913 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 1235.21.910 Boehringer Ingelheim Investigational Site — Hollywood, Florida, United States
• 1235.21.903 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• 1235.21.905 Boehringer Ingelheim Investigational Site — Tucker, Georgia, United States
• 1235.21.916 Boehringer Ingelheim Investigational Site — Olive Branch, Mississippi, United States
• 1235.21.915 Boehringer Ingelheim Investigational Site — Hickory, North Carolina, United States
• 1235.21.906 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1235.21.902 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1235.21.904 Boehringer Ingelheim Investigational Site — Penndel, Pennsylvania, United States
• 1235.21.908 Boehringer Ingelheim Investigational Site — Carrollton, Texas, United States
• 1235.21.909 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1235.21.912 Boehringer Ingelheim Investigational Site — Killeen, Texas, United States
• 1235.21.911 Boehringer Ingelheim Investigational Site — Ettrick, Virginia, United States
• 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
• 1235.21.302 Boehringer Ingelheim Investigational Site — Acapulco, Mexico
• 1235.21.304 Boehringer Ingelheim Investigational Site — Aguascalientes, Mexico
• 1235.21.301 Boehringer Ingelheim Investigational Site — Guadalajara, Mexico
• 1235.21.303 Boehringer Ingelheim Investigational Site — Guadalajara, Mexico
• 1235.21.305 Boehringer Ingelheim Investigational Site — Guadalajara, Mexico
• 1235.21.901 Boehringer Ingelheim Investigational Site — Long Beach, California, United States

Full record on ClinicalTrials.gov

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