NCT01766505

Brief Summary

The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

9 active sites

Status
terminated

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

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
1.1 years 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

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

January 10, 2013

Last Update Submit

March 12, 2014

Conditions

Hypertension

Keywords

hypertension, heart failure, candesartan, losartan

Outcome Measures

Primary Outcomes (1)

  • change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks

    baseline, 16 weeks

Secondary Outcomes (9)

  • change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks

    baseline, 8 weeks

  • change from baseline average sitting SBP(systolic blood pressure)at 8 weeks

    baseline, 8 weeks

  • change from baseline average sitting SBP(systolic blood pressure)at 16 weeks

    baseline, 16 weeks

  • ratio of normalize from baseline blood pressure at 16 weeks

    baseline, 16 weeks

  • response ratio from baseline blood pressure at 16 weeks

    baseline, 16 weeks

  • +4 more secondary outcomes

Other Outcomes (2)

  • rate of adverse event

    up to 16 weeks

  • medication history

    up to 16 weeks

Study Arms (2)

Candemore tablet

EXPERIMENTAL

Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks

Drug: Candemore tablet

Cozzar tablet

ACTIVE COMPARATOR

Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks

Drug: Cozzar tablet

Interventions

Candemore tabletDRUG

Candemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks. dosage is depends on the sitting blood pressure.

Candemore tablet
Cozzar tabletDRUG

Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure

Cozzar tablet

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male patients who aged above 19 and below 75
  • Patients with 90\~109mmHg average sitting DBP on baseline
  • NYHA class 2\~4
  • Patients who agreement with written informed consent

You may not qualify if:

  • above 110mmHg sitting DBP and/or 180mmHg sitting SBP
  • Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening
  • Patients who have medical history that secondary hypertension or rule out secondary hypertension
  • malignant hypertension
  • symptomatic postural hypotension
  • right heart failure due to pulmonary disease
  • etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chungnam national university hospital

Daejeon, 301-721, South Korea

Location

The catholic university of Korea, Daejeon st. Mary's Hospital

Daejeon, 301-723, South Korea

Location

Konyang university hospital

Daejeon, 302-718, South Korea

Location

Eulji University Hospital

Daejeon, 302-799, South Korea

Location

Chunnam National University Hospital

Gwangju, 501-757, South Korea

Location

Kwangju Christian Hospital

Gwangju, 503-715, South Korea

Location

Presbyterian Medical Center

Jeonju, 560-750, South Korea

Location

Chunbuk National University Hospital

Jeonju, 561-712, South Korea

Location

ST.Carollo hospital

Suncheon, 540-719, South Korea

Location

MeSH Terms

Conditions

HypertensionHeart Failure

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Myungho Jeong, phD

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 11, 2013

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

KR(9)