An Open-Label, Long-Term Study of Telmisartan Plus Amlodipine Fixed-Dose Combination

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either...

Date First Received: February 8, 2008

Last Updated: July 14, 2008

Verified by: Boehringer Ingelheim Pharmaceuticals, July 2008

Clinical Trial Phase: Phase 3 | Start Date: January 2008

Overall Status: Recruiting

Estimated Enrollment: 200

Brief Summary

Official Title: “An Open-Label, Long-Term Study of Telmisartan Plus Amlodipine Fixed-Dose Combination”

Condition Keyword(s):

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Study Type: Interventional

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

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

  • Drug: telmisartan40/amlodipine5
    • T40mg/A5mg/day
  • Drug: telmisartan80/amlodipine5
    • T80mg/A5mg/day

Outcome Measures for this Clinical Trial

Primary Measures

  • The safety of telmisartan plus amlodipine FDC during 1 year treatment will be assessed based on the following endpoints: Incidence of adverse events, Changes in BP and PR, Seated PR, Laboratory parameters, and ECG.
    • Time Frame: 56 Weeks

Secondary Measures

  • The secondary endpoints are: To assess add on antihypertensive effect after 8 weeks of treatment with titrating up to T80/A5. To discuss attenuation of antihypertensive effect.
    • Time Frame: 8 Weeks and 56 Weeks

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 1. Patients with essential hypertension
  • 2. Outpatient

Exclusion Criteria:

  • Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials" Patients who have met any of the exclusion criteria defined in the "non-responder trials"

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

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

Additional Information

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618774

Study ID Number: 1235.16

ClinicalTrials.gov Identifier: NCT00618774

Health Authority: Japan: Ministry of Health, Labor and Welfare

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