PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

NCT ID: NCT02058446

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-03-31

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Amlodipine/Valsartan Single-Pill Combination

Group Type: EXPERIMENTAL

Amlodipine/Valsartan

Intervention Type: DRUG

Amlodipine/Valsartan: 5 mg/80 mg

Interventions

Amlodipine/Valsartan

Amlodipine/Valsartan: 5 mg/80 mg

Intervention Type: DRUG

Other Intervention Names

Am-Daiwen®

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TSH Biopharm Corporation Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuo-Yang Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

TSHAM1301

Identifier Type: -

Identifier Source: org_study_id