Status:
COMPLETED
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure an...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged at least 18 years at the date of signing the consent form
- For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
- 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring
- Exclusion criteria:
- mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
- any clinically significant hepatic impairment
- severe renal impairment
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
- current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
- other conditions or situations that could put potential participants at unacceptable risk due to participation in this study
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01204398
Start Date
November 1 2010
Last Update
June 27 2014
Active Locations (1)
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1
1235.31.86001 Boehringer Ingelheim Investigational Site
Shanghai, China