Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
35–84
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 35 years, but less than 85 years of age
Mean SBP ≥ 150 mm Hg and mean DBP \< 90 mm Hg at the randomisation visit (visit 2), according to WHO definitions of ISH (excluding the subgroup of borderline ISH)
Hypertensive patients not on current antihypertensive therapy or able to stop current treatment for a period of up to 8 - 10 weeks without endangering the health of the patient (investigator's discretion)
Ability to provide written informed consent
You may not be if
Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
1. are not surgically sterile; and/or
2. are nursing
3. are of child-bearing potential and are not practicing acceptable means of birth control or do NOT plan to continue using this method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives
Mean systolic blood pressure ≥ 180 mmHg at the randomization Visit 2
Known or suspected secondary hypertension
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
1. Serum glutamic pyruvate transaminase (ALT) or serum glutamic oxaloacetic transaminase (AST) \> than 2 times the upper limit of normal range
2. Serum creatinine \> or 1.8 mg/dl (or 159 µmol/l)
Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
Clinically relevant hypokalemia or hyperkalemia
Uncorrected volume or sodium depletion
Primary aldosteronism
Hereditary fructose intolerance
Biliary obstructive disorders
Symptomatic congestive heart failure
Angina pectoris or previous myocardial infarction
Previous percutaneous transluminal coronary angioplasty or coronary artery bypass craft
Previous cerebrovascular accident or hypertensive encephalopathy or transient ischemic attack(s)
Current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigators decision) by the start of the run-in period. Any pre-treatment with diuretics, ACE inhibitors or angiotensin II receptor antagonists requires an extension of the run-in period from 2 to 4 weeks for adequate wash-out
Atrial fibrillation (controlled or otherwise) or any other clinically relevant cardiac arrhythmias as determined by the clinical investigator
Hemodynamically relevant aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy or other outflow obstruction of the left ventricle
Patients with non-insulin-dependent diabetes mellitus requiring treatment with oral hypoglycemics who fail to meet the following criteria by history:
1. Fasting blood glucose less than 200 mg/dl (11.1 mmol/l)
2. Therapy stabilized for at least one month prior to start of placebo run-period
Patients with diabetes mellitus requiring treatment with insulin
Patients who have previously experienced symptoms characteristics of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
Known drug or alcohol dependency
Any investigational therapy within one month of signing the informed consent form and during the trial
Known hypersensitivity to any component of the formulation of telmisartan or hydrochlorothiazide including allergy to sulfonamides
Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
Gout (contraindication for treatment with HCTZ)
Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan or hydrochlorothiazide
Clareo Health | Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)
