Status:
COMPLETED
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
Eligibility Criteria
Inclusion
- Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)
Exclusion
- Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
- Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
- Patients having a history of the following within the last six months:
- myocardial infarction,
- unstable angina pectoris,
- percutaneous coronary intervention,
- severe heart failure,
- hypertensive encephalopathy, cerebrovascular accident (stroke) or
- transient ischaemic attack.
- Patients with clinically significant abnormal laboratory values at screening.
- Patients with secondary HTN.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1011 Patients enrolled
Trial Details
Trial ID
NCT00430950
Start Date
February 1 2007
End Date
October 1 2008
Last Update
January 10 2019
Active Locations (41)
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1
Bruges, Belgium
2
Brussels, Belgium
3
Drongen, Belgium
4
Godinne, Belgium