Clinical trial NCT02058446: PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension
Official title: An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: TSH Biopharm Corporation Limited
Sponsor class: INDUSTRY
First posted: 2014-02-10
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.
timeFrame: 6 weeks from baseline
Secondary outcomes:
measure: To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
timeFrame: 6 weeks from baseline
measure: To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment
timeFrame: 6 weeks from baseline
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Kuo-Yang Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: