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PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT02058446
First received: February 4, 2014
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Essential Hypertension
Drug: Amlodipine/Valsartan
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension

Resource links provided by NLM:


Further study details as provided by TSH Biopharm Corporation Limited:

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. [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
Amlodipine/Valsartan Single-Pill Combination
Drug: Amlodipine/Valsartan
Amlodipine/Valsartan: 5 mg/80 mg
Other Name: Am-Daiwen®

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058446

Locations
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
TSH Biopharm Corporation Limited
Investigators
Principal Investigator: Kuo-Yang Wang, MD, PhD Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT02058446     History of Changes
Other Study ID Numbers: TSHAM1301
Study First Received: February 4, 2014
Last Updated: February 6, 2014
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Amlodipine, valsartan drug combination
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014