Essential Hypertension
Conditions
Brief summary
The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label, non-randomized approach. The study also wants to investigate the safety of Amlodipine/Valsartan combination during the 6-week treatment period.
Interventions
Amlodipine/Valsartan: 5 mg/80 mg
Sponsors
TSH Biopharm Corporation Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are 20-80 years of age * Patients with essential hypertension (90 mmHg ≤ DBP ≤ 110 mmHg and/or 140 mmHg ≤ SBP ≤ 180 mmHg) whose BP is not adequately controlled with amlodipine (or another CCB) alone or with valsartan (or another ARB) alone, or with any antihypertensive monotherapy. * Agree to and are able to follow the study procedures * Understand the nature of the study, and have signed informed consent forms
Exclusion criteria
* Patients with any of the following conditions: 1. Malignant (or history of malignant) hypertension 2. Secondary hypertension 3. Severe hypertension (mean sitting DBP ≥ 110 mmHg and/or mean sitting SBP ≥ 180 mmHg) 4. A history of hypertensive encephalopathy or cerebrovascular accident 5. Cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization 6. New York Heart Association class III -IV congestive heart failure 7. Second- or third-degree heart block 8. Angina pectoris 9. Significant arrhythmia or valvular heart disease 10. Significant pancreatic, hepatic, or renal disease 11. Diabetes requiring insulin treatment or poorly controlled type 2 diabetes * Patients with known contraindication or a history of allergy to CCBs or ARBs. * Female patients who are pregnant or lactating. * Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study * Patients is currently participating in any other clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period. | 6 weeks from baseline |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment | 6 weeks from baseline |
| To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment | 6 weeks from baseline |
Countries
Taiwan
Outcome results
None listed