PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

November 11, 2015 updated by: TSH Biopharm Corporation Limited

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Amlodipine/Valsartan Single-Pill Combination
Amlodipine/Valsartan: 5 mg/80 mg
Other Names:
  • Am-Daiwen®

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 6 weeks from baseline
6 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
Time Frame: 6 weeks from baseline
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
Time Frame: 6 weeks from baseline
6 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kuo-Yang Wang, MD, PhD, Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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