PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

Essential Hypertension Clinical Trial

Official title:

An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058446
• Other study ID #: TSHAM1301
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2014
• Last updated: November 11, 2015
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2014
• Source: TSH Biopharm Corporation Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Amlodipine/Valsartan
Amlodipine/Valsartan: 5 mg/80 mg

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
TSH Biopharm Corporation Limited

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment		6 weeks from baseline	No
Secondary	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	No