Prospective, open label TElmisartan/AMlodipine single pill STudy to Assess the efficacy in patients with essential hypertension who are not controlled on RAASi mono-therapy being switched. - Teamsta-switch

• Conditions: Hypertension; MedDRA version: 12.1Level: LLTClassification code 10005757Term: Blood pressure systolic abnormal; MedDRA version: 12.1Level: LLTClassification code 10005728Term: Blood pressure abnormal; MedDRA version: 12.1Level: LLTClassification code 10005736Term: Blood pressure diastolic abnormal

• Registration Number: EUCTR2009-017336-40-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-11
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

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 uncontrolled hypertension as defined SBP =140 mmHg and SBP=130 mmHg in patients with diabetes or renal impairment or DBP =90 mmHg and DBP=80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (ACE inhibition, ARB and Renin-inhibitors) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.

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 who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
2.Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
3.Mean in-clinic seated cuff SBP =180 mmHg and SBP =160 mmHg in patients with diabetes or renal impairment or DBP =110 mmHg and DBP =100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
4.Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 ?mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
5.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
6.Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L).
7.Uncorrected sodium or volume depletion.
8.Primary aldosteronism.
9.Hereditary fructose intolerance.
10.Congestive heart failure NYHA functional class CHF III-IV (Refer to Appendix 10.1).
11.Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
12.Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x ASAT/ALAT values). (Refer to Appendix 10.3)
13.Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.
14.History of drug or alcohol dependency within six months prior to signing the informed consent form.
15.Any investigational drug therapy within one month of signing the informed consent.
16.Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
17.History of non-compliance or inability to comply with prescribed medications or protocol procedures.
18.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