Hypertension
Conditions
Keywords
Hypertension
Brief summary
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Interventions
amlodipine/losartan (COZAAR XQ) prescribed according to the current local label
Sponsors
Organon and Co
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant with essential hypertension * Participant who is treated with COZAAR XQ within local label for the first time
Exclusion criteria
* Participant who is treated with COZAAR XQ before contract and out of enrollment period * Participant who has a contraindication to COZAAR XQ according to the local label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with any adverse experience | Up to 14 days after last treatment |
| Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator | At 8 weeks after first treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator | At 24 weeks after first treatment |
Outcome results
None listed