An eight-week randomised, 4-arm, double-blind study to compare the efficacy and safety of combinations of telmisartan 40mg + amlodipine 5mg versustelmisartan 80mg + amlodipine 5mg versus amlodipine 5mg monotherapy versus amlodipine 10mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 5mg monotherapy.

• Conditions: essential hypertension

• Registration Number: EUCTR2007-002409-36-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1012

Inclusion Criteria

1.patients aged at least 18 years at the date of signing the consent form
2.diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study (inadequate control defined as seated DBP = 95 mmHg if on antihypertensive treatment or seated DBP = 100 mmHg if treatment naive)
3.failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy (defined as seated DBP = 90 mmHg at six weeks i.e. at Visit 3)
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
3.mean seated SBP = 200 mmHg and/or mean seated DBP = 120 mmHg at Visit 1 or 2 or mean seated SBP = 180 mmHg and/or mean seated DBP = 120 mmHg at the end of the run-in period (Visit 3)
4.any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
5.severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 µmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified