NCT03255551

Brief Summary

Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

August 16, 2017

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.

    Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension

    6 month

Interventions

amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Estimated total number of patients: 3,150 Estimated number of centers: 37

You may qualify if:

  • Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy
  • In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure
  • Patients who were changed to amosartan while using other hypertensive agents

You may not qualify if:

  • Patients with hypersensitivity to dihydropyridine derivatives of amosartan
  • Women who are pregnant or who may be pregnant and breastfeeding
  • Patients with severe hepatic dysfunction
  • Patients with severe aortic stenosis
  • Patients at risk of shock
  • Patients participating in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.

    PMID: 22035131BACKGROUND
  • Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003 Jun 28;326(7404):1427. doi: 10.1136/bmj.326.7404.1427.

    PMID: 12829555BACKGROUND
  • Choi SM, Seo MJ, Kang KK, Kim JH, Ahn BO, Yoo M. Beneficial effects of the combination of amlodipine and losartan for lowering blood pressure in spontaneously hypertensive rats. Arch Pharm Res. 2009 Mar;32(3):353-8. doi: 10.1007/s12272-009-1307-x. Epub 2009 Apr 23.

    PMID: 19387578BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Bundang Hospital

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 21, 2017

Study Start

January 1, 2014

Primary Completion

June 30, 2015

Study Completion

December 31, 2015

Last Updated

August 21, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share