NCT02433119

Brief Summary

A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Mar 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2016

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

April 29, 2015

Last Update Submit

April 11, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

    Baseline, Week 8

Secondary Outcomes (4)

  • Change from baseline in MSDBP

    Baseline, Week 4

  • Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

    Baseline, Week 4 and 8

  • Control rate in blood pressure

    Baseline, Week 8

  • Responder rate in blood pressure

    Baseline, Week 8

Study Arms (2)

Amlodipine orotate & Valsartan

EXPERIMENTAL

Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks

Drug: OROSARTAN® 5/160mg

Valsartan & Hydrochlorothiazide

ACTIVE COMPARATOR

Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks

Drug: CODIOVAN® 160/12.5mg

Interventions

OROSARTAN® 5/160mgDRUG
Amlodipine orotate & Valsartan
CODIOVAN® 160/12.5mgDRUG
Valsartan & Hydrochlorothiazide

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged or over
  • A patient who was diagnosed with essential hypertension at screening(Visit 1)
  • A patient understood objective of this clinical trial and gave their written informed consent voluntarily

You may not qualify if:

  • A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
  • A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
  • Medical history or evidence of a secondary form of hypertension
  • A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

March 16, 2015

Primary Completion

September 8, 2016

Study Completion

September 8, 2016

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

KR(1)