Status:
COMPLETED
The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with ess...
Detailed Description
* Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data t...
Eligibility Criteria
Inclusion
- 20 aged or over
- Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)
Exclusion
- Patients with too high Blood pressure
- •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
- Secondary hypertension or suspected to be
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT01828359
Start Date
August 1 2010
End Date
January 1 2013
Last Update
April 10 2013
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