TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over encapsulated tablets or telmisartan 80 mg tablets as first line therapy in patients with severe HyperTeNsion: A Phase III, 8-week, randomised, double-blind, double-dummy, forced-titration comparison [TEAMSTA severe HTN] - TEAMSTA Severe HT

Conditions: Severe Hypertension
MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

Registration Number: EUCTR2008-000873-40-BG

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 760

Inclusion Criteria

All of the following inclusion criteria must be met in male and female patients.
1.Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
2.Age 18 years or older
3.Patients with severe hypertension as defined SBP = 180 mmHg and DBP = 95 mmHg
4.Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator’s discretion)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pre-menopausal women (last menstruation =1 year prior to signing informed consent) who:
a)are not surgically sterile; or
b)are nursing, or
c)are pregnant, or
d)are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial.
The only acceptable methods of birth control are:
•Intra Uterine Device (IUD)
•Oral (must have started therapy at least one month in advance of the trial)
•Implantable or injectable contraceptives
•Estrogen patch
2.Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
3.Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
4.Mean in-clinic seated cuff SBP = 200 mmHg and/or DBP =120 mmHg during any visit
5.Renal dysfunction as defined by the following laboratory parameters:
Serum creatinine >3.0 mg/dL (or >265 mmol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
6.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
7.Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 or >5.5 mEq/L, may be rechecked for suspected error in result)
8.Uncorrected sodium or volume depletion
9.Primary aldosteronism.
10.Hereditary fructose intolerance
11.Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
12.Congestive heart failure NYHA functional class CHF III-IV (Refer to Appendix 10.3)
13.Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run-in period)
14.Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
15.Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
16.Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C =10%
17.Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
18.History of drug or alcohol dependency within six months prior to signing the informed consent form
19.Concomitant administration of any medications known to affect BP, except medications allowed by the protocol
20.Any investigational drug therapy within one month of signing the informed consent
21.Known hypersensitivity to any component of the trial drugs (telmisartan, amlodipine, or placebo)
22.History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120% especially during run-in)
23.Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication