Official Title: “An Eight-Week Randomized, 4-Arm, Double-Blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy”

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: fixed dose combination of telmisartan+amlodipine
• Drug: amlodipine

Primary Measures

• The co primary endpoints are the change from baseline in DBP and the rate of incidence of oedema adverse events.
  • Time Frame: 8 weeks
    

Secondary Measures

• the change from baseline in seated SBP. the proportion of patients achieving DBP control
  • Time Frame: 8 weeks
    

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
• 3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
• 4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
• 5. willing and able to provide written informed consent (in accordance with Good Clinical
• Practice and local legislation).

Exclusion Criteria:

• 1. 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 over 200 mmHg and/or mean seated DBP over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 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 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
• 6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
• 7. clinically relevant hyperkalaemia
• 8. uncorrected volume or sodium depletion.
• 9. primary aldosteronism.
• 10. hereditary fructose or lactose intolerance

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00558428

Study ID Number: 1235.5

ClinicalTrials.gov Identifier: NCT00558428

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products