PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TSH Biopharm Corporation Limited
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Valsartan

Criteria

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