The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy
1 other identifier
interventional
199
0 countries
N/A
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 essential hypertension uncontrolled with losartan 100mg monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Aug 2010
Typical duration for phase_4 hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 7, 2013
CompletedFirst Posted
Study publicly available on registry
April 10, 2013
CompletedApril 10, 2013
April 1, 2013
2.4 years
April 7, 2013
April 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Baseline, Week 8
Secondary Outcomes (3)
Change from baseline in MSDBP
Baseline, week 4
Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)
Baseline, Week 4 and 8
Blood pressure responder rate
Baseline, Week 4 and 8
Study Arms (2)
Amosartan® tab
EXPERIMENTALAmlodipine 5mg /Losartan 100mg
Cozaar® plus pro tab
ACTIVE COMPARATORLosartan 100mg/ HCTZ 12.5mg
Interventions
comparison of different combination of anti-hypertension drug
comparison of different combination of anti-hypertension drug
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taehoon Ahn, Ph.D.
Gachon University Gil Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2013
First Posted
April 10, 2013
Study Start
August 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 10, 2013
Record last verified: 2013-04