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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Hypertension; Congestive Heart Failure

Treatments: Drug: Atacand tablet; Drug: Candemore tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682564

m106CHF11E

Details and patient eligibility

About

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

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 2 patient groups

Candemore tablet

Experimental group

Description:

Candemore 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)

Treatment:

Drug: Candemore tablet

Atacand tablet

Active Comparator group

Description:

Atacand 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)

Treatment:

Drug: Atacand tablet