search
Back to results

PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Amlodipine/Valsartan
Sponsored by
TSH Biopharm Corporation Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Amlodipine/Valsartan Single-Pill Combination

Outcomes

Primary Outcome Measures

To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.

Secondary Outcome Measures

To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment

Full Information

First Posted
February 4, 2014
Last Updated
November 11, 2015
Sponsor
TSH Biopharm Corporation Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT02058446
Brief Title
PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension
Official Title
An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TSH Biopharm Corporation Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Amlodipine/Valsartan Single-Pill Combination
Intervention Type
Drug
Intervention Name(s)
Amlodipine/Valsartan
Other Intervention Name(s)
Am-Daiwen®
Intervention Description
Amlodipine/Valsartan: 5 mg/80 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
Time Frame
6 weeks from baseline
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: Malignant (or history of malignant) hypertension Secondary hypertension Severe hypertension (mean sitting DBP ≥ 110 mmHg and/or mean sitting SBP ≥ 180 mmHg) A history of hypertensive encephalopathy or cerebrovascular accident Cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization New York Heart Association class III -IV congestive heart failure Second- or third-degree heart block Angina pectoris Significant arrhythmia or valvular heart disease Significant pancreatic, hepatic, or renal disease 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo-Yang Wang, MD, PhD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

We'll reach out to this number within 24 hrs