Hypertension
Conditions
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.
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 to external data sources (medical records and paper case report forms). * Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges. * Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA
Interventions
DRUGAmosartan® tab
comparison of different combination of anti-hypertension drug
DRUGCozaar® plus pro tab
comparison of different combination of anti-hypertension drug
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline, Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Rate of patients who achieved target blood pressure (MSSBP \< 140 mmHg and MSDBP \< 90 mmHg), or MSSBP decrease \> 20 mmHg from baseline or MSDBP decrease \> 10 mmHg from baseline. |
Outcome results
None listed