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NCT Number: NCT02058446

PMS Study of Amlodipine/Valsartan 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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine/Valsartan

Drug

Amlodipine/Valsartan: 5 mg/80 mg

Other names: Am-Daiwen®

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

Sponsors and collaborators

Lead sponsor

TSH Biopharm Corporation Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2014
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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