Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline)
Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2)
A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3)
Age 18 or older
Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
You may not be if
Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):
* Who are not surgically sterile (hysterectomy, tubal ligation)
* Who are NOT practising acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the trial. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives
* Who have a positive urine pregnancy test
* Who are nursing
Mean seated diastolic blood pressure (DBP) \> 114 mmHg or mean seated systolic BP \> 200 mmHg, by manual cuff
Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate oxaloacetate transaminase) (AST) greater than two times the upper limit of normal
* Serum creatinine \> 1.8 mg/dl (or 159 µmol/l)
Clinically relevant hypokalemia
Known or suspected secondary hypertension
Known bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney.
Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)
Unstable angina within the past 3 months; stable angina where a change in nitrate therapy (dose or frequency) during the run-in period was required
Stroke within the past 6 months prior to start of run-in period
Myocardial infarction or cardiac surgery within the past 3 months prior to start of run-in period
PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to start of run-in period
Previous history of angioedema
Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
Patients with unstable insulin-dependent diabetes mellitus (risk of hypoglycemia or HbA1c ≥ 10 % in history within 6 months prior to start of run-in period)
Known drug or alcohol dependency within the past 6 months period prior to start of run-in period
Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
Patients receiving any investigational therapy within one month of signing the informed consent form
Known hypersensitivity to any component of the formulations
Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of trial medication
Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
Clareo Health | Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension
