- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058446
PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension
An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Amlodipine/Valsartan Single-Pill Combination
|
Amlodipine/Valsartan: 5 mg/80 mg
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
Time Frame: 6 weeks from baseline
|
6 weeks from baseline
|
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
|
6 weeks from baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kuo-Yang Wang, MD, PhD, Taichung Veterans General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Valsartan
- Amlodipine, Valsartan Drug Combination
Other Study ID Numbers
- TSHAM1301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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