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CompletedNCT02058446Updated Nov 13, 2015

PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

A Phase 4 interventional study of Amlodipine/Valsartan in Essential Hypertension, sponsored by TSH Biopharm Corporation Limited. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-13.

Sponsored by TSH Biopharm Corporation Limited · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Hypertension
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Study group

    Amlodipine/Valsartan Single-Pill Combination

    Drug: Amlodipine/Valsartan

Interventions

  • DrugAmlodipine/Valsartan

    Amlodipine/Valsartan: 5 mg/80 mg

    Also known as: Am-Daiwen®

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment

    Time frame: 6 weeks from baseline

  2. 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

06

Study locations

1 site
  • Taichung Veterans General Hospital
    Taichung, 40705, Taiwan
07

Registry details

Key details

Study ID
NCT02058446
Lead sponsor
TSH Biopharm Corporation Limited
Responsible party
Sponsor
First posted
Feb 10, 2014
Start date
Oct 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Nov 13, 2015

Study contacts

Kuo-Yang Wang, MD, PhD
principal investigator · Taichung Veterans General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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