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PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02058446
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : November 13, 2015
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Amlodipine/Valsartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study group
Amlodipine/Valsartan Single-Pill Combination
Drug: Amlodipine/Valsartan
Amlodipine/Valsartan: 5 mg/80 mg
Other Name: Am-Daiwen®

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02058446

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Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
TSH Biopharm Corporation Limited
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Principal Investigator: Kuo-Yang Wang, MD, PhD Taichung Veterans General Hospital
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Responsible Party: TSH Biopharm Corporation Limited Identifier: NCT02058446    
Other Study ID Numbers: TSHAM1301
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: February 2014
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists