Status:
COMPLETED
Open Label Study Telmisartan and Amlodipine in Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) dur...
Eligibility Criteria
Inclusion
- patients aged at least 18 years
- diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
- failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.
Exclusion
- 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
- development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
- discontinuation from the preceding trial because of any adverse event or any other reason
- known or suspected secondary hypertension
- mean seated Systolic Blood Pressure =\> 180 mmHg and/or mean seated Diastolic Blood Pressure =\> 120 mmHg at any visit
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
976 Patients enrolled
Trial Details
Trial ID
NCT00614380
Start Date
January 1 2008
Last Update
February 13 2014
Active Locations (122)
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1
1235.7.32004 Boehringer Ingelheim Investigational Site
Aywaille, Belgium
2
1235.7.32010 Boehringer Ingelheim Investigational Site
Gozée, Belgium
3
1235.7.32008 Boehringer Ingelheim Investigational Site
Linkebeek, Belgium
4
1235.7.32003 Boehringer Ingelheim Investigational Site
Mol, Belgium