To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure

Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-center, Phase IV Study to Compare and Evaluate the Efficacy and Safety of Candemore Tab and Atacand Tab.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01682564

Acronym

CANTABILE

Enrollment

169

Registered

2012-09-11

Start date

2012-01-31

Completion date

2014-10-31

Last updated

2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Hypertension

Keywords

Candemore, Atacand, Candesartan cilexetil, Primary Hypertension, Congestive Hypertension

Brief summary

To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure

Detailed description

This is an open label, randomized, active drug comparative, Parallel group, Multi-center, phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured SBP ≥ 100mmHg and DBP \> 60mmHg. Maximum dose is 16mg/day.

Interventions

DRUGCandemore tablet

* Initial dose : 4mg/day if SBP\<140mmHg and/or DBP\<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg * dose escalation : double dose if SBP≥100mmHg and DBP\>60mmHg (maximum dose 16mg/day)

DRUGAtacand tablet

* Initial dose : 4mg/day if SBP\<140mmHg and/or DBP\<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg * dose escalation : double dose if SBP≥100mmHg and DBP\>60mmHg (maximum dose 16mg/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* willing and able to provide written informed consent * age 20 years or older * patient with congestive heart failure, taking treatment medicine and NYHA grade II\ III * patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit

Exclusion criteria

* Known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease) * blood creatinine level ≥ 2.5mg/dl * blood potassium level \> 5.5mEq/L * blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic dysfunction, cholestasis * pregnant or breast-feeding * premenopausal women not using adequate contraception * patient has history about hypersensitivity or taboo of investigational product * patient with lactose intolerance or Lapp lactase deficiency or glucode-galactose malabsorption * administration of other study drugs within 1 month prior to screening * history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months * in investigator's judgement

Design outcomes

Primary

Measure	Time frame
Mean sitting Systolic Blood Pressure	After 12 weeks of treatment

Secondary

Measure	Time frame	Description
Mean Sitting Diastolic Blood Pressure	After 12 weeks of treatment	—
echocardiography	After 12 weeks of treatment	Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
Blood Creatinine and Potssium level	After 4 and 12 weeks of treatment	—
NYHA class	After 12 weeks of treatment	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026