A randomised, double-blind, double dummy, active controlled, parallelgroup, forced titration study to compare the fixed-dose combination ofTelmisartan 80mg plus Hydrochlorothiazide 25mg (T80/HCTZ25)versus Telmisartan 80mg (T80) monotherapy as first line therapy inpatients with severe hypertensio

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

Registration Number: EUCTR2008-007711-32-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: 840

Inclusion Criteria

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 at randomisation
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 contraceptives
Implantable or injectable contraceptives
Estrogen patch
Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
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
5. Renal dysfunction as defined by the following laboratory parameters:
Serum creatinine >3.0 mg/dL (or >265 umol/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 mmol/L or >5.5 mmol/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 3 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 6 months prior to signing the informed consent form
19. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
20. Any investigational drug therapy within 1 month of signing the informed consent
21. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Key secondary objective:<br><br>Change from baseline in mean seated trough cuff systolic blood pressure (SBP) at w5, w3.;Primary end point(s): To show that the fixed dose combination T80/HCTZ25 is superior vs. the monotherapy T80 (after 6 weeks treatment with highest doses) with regard to: <br>•Change from baseline in mean seated trough cuff systolic blood pressure (SBP) to final visit (w7)<br>;Main Objective: The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff SBP compared to the monotherapy of T80 in patients with severe hypertension.<br><br>

Secondary Outcome Measures

Name	Time	Method

Related Trials