Official Title: “An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension”

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A10 or T80/A10 during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving diastolic blood pressure (DBP) control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

Study Type: Interventional

Study Design: Treatment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
  • telmisartan/amlodipine fixed dose combination (40mg/10mg)
• Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg
  • telmisartan/amlodipine fixed dose combination (80mg/10mg)

Primary Measures

• Proportion of patients achieving diastolic blood pressure control
  • Time Frame: six months
    

Secondary Measures

• Change from baseline in seated blood pressure
  • Time Frame: six months
    

Inclusion Criteria:

• diagnosis of essential hypertension

Exclusion Criteria:

• pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
• development of any condition in the preceding trial that could be worsened by T40/A10 or T80/A10.
• discontinuation from the preceding trial. known or suspected secondary hypertension. mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at any visit. 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.
• any new drug or alcohol dependency since signing consent of the preceding trial.
• concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
• 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 <80% or >120%) during the preceding trial.
• administration of ARBs or dihydropyridine CCBs (apart from 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  

Overall Contact: Boehringer Ingelheim Study Coordinator  clintriage@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00624052

Study ID Number: 1235.8

ClinicalTrials.gov Identifier: NCT00624052

Health Authority: Ireland: Irish Medicines Board