Official Title: “An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg 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/A5 or T80/A5 during long-term open-label treatment.

Study Type: Interventional

Study Design: Treatment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: telmisartan/amlodipine 40/5 mg fixed combination
• Drug: telmisartan/amlodipine 80/5 mg fixed combination

Primary Measures

• The primary endpoint is the proportion of patients achieving DBP control
  • Time Frame: Six months
    

Secondary Measures

• change from baseline in seated through DBP change frmo baseline in seated SBP proportion of patients achieving DBP response proportion of patients achieving SBP response
  • Time Frame: Six months
    

Inclusion Criteria:

• 1. patients aged at least 18 years
• 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
• 3. failure to respond to six weeks treatment with A5 in the run-in period of the preceding trial.

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
• 2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either T40/A5 or T80/A5
• 3. discontinuation from the preceding trial because of any adverse event or any other reason
• 4. known or suspected secondary hypertension
• 5. mean seated SBP => 180 mmHg and/or mean seated DBP => 120 mmHg at any visit

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.rdg@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00614380

Study ID Number: 1235.7

ClinicalTrials.gov Identifier: NCT00614380

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