NCT02058446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 13, 2015

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

February 4, 2014

Last Update Submit

November 11, 2015

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Study group

EXPERIMENTAL

Amlodipine/Valsartan Single-Pill Combination

Drug: Amlodipine/Valsartan

Interventions

Amlodipine/ValsartanDRUG

Amlodipine/Valsartan: 5 mg/80 mg

Also known as: Am-Daiwen®
Study group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ValsartanTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmlodipineDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical Preparations

Study Officials

  • Kuo-Yang Wang, MD, PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 10, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 13, 2015

Record last verified: 2014-02

Locations

TW(1)