PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

Phase 4

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Amlodipine/Valsartan

• Registration Number: NCT02058446
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Amlodipine/Valsartan	Amlodipine/Valsartan Single-Pill Combination

Primary Outcome Measures

Name	Time	Method
To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.	6 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment	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	6 weeks from baseline

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan