Official Title: “An Eight-Week Randomised, Double-Blind Study to Compare the Fixed-Dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy”

The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.

Study Type: Interventional

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

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

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

Primary Measures

• Change from baseline in seated trough DBP after 8 weeks of randomised treatment
  • Time Frame: 8 weeks
    

Secondary Measures

• Change from baseline in seated SBP at 8 weeks. Proportion of patients achieving DBP control, DBP response, SBP response and proportion having optimal BP, normal BP, high/normal BP and high BP at 8 weeks. Safety and tolerability.
  • Time Frame: 8 weeks
    

Inclusion Criteria:

• diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated DBP >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naïve).
• failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP >= 90 mmHg.)
• able to stop any current antihypertensive therapy without unacceptable risk to the patient.
• willing and able to provide written informed consent.

Exclusion Criteria:

• pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
• known or suspected secondary hypertension.
• mean seated SBP >=200 mmHg and/or mean seated DBP >= 120 mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at the randomisation visit or at any time during randomised treatment.
• any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
• clinically relevant hyperkalaemia.
• uncorrected volume or sodium depletion.
• primary aldosteronism.
• hereditary fructose or lactose intolerance.
• symptomatic congestive heart failure.
• patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs.
• history of drug or alcohol dependency within the six months prior to signing consent.
• concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.
• hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
• known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine CCBs.)
• non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.
• current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.
• chronic administration of any medication known to affect blood pressure, other than the trial medication.
• any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

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 January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00553267

Study ID Number: 1235.6

ClinicalTrials.gov Identifier: NCT00553267

Health Authority: Australia: Responsilble Ethics Committee Austria: Federal Office for Safety in Health Care Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Great Britain: MHRA Ireland: Irish Medic