PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

TSH Biopharm

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: Amlodipine/Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02058446

TSHAM1301

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Study group

Experimental group

Description:

Amlodipine/Valsartan Single-Pill Combination

Treatment:

Drug: Amlodipine/Valsartan