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

Hypertension Clinical Trial

— CANTABILE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682564
• Other study ID #: m106CHF11E
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2012
• Last updated: September 22, 2015
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Hypertension

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Daedong hospital	Busan	Dongnae-gu Myeongnyun-dong
Korea, Republic of	Dong-A university medical center	Busan	Seo-gu Dongdaesin-dong
Korea, Republic of	Inje university haeundae paik hospital	Busan	Haeundae-gu Heaundae-ro 875
Korea, Republic of	Inje university pusan hospital	Busan	Busanjin-gu Gaegum-dong
Korea, Republic of	Kosin university gospel hospital	Busan	Seo-gu Amnam-dong
Korea, Republic of	Maryknoll medical center	Busan	Jung-gu Daecheong-dong
Korea, Republic of	Samsung changwon hospital	Changwon	Masanhoiwon-gu Hapseong-dong 50
Korea, Republic of	Daegu catholic univ. medical center	Daegu	Nam-gu Daemyung-dong
Korea, Republic of	Daegu fatima hospital	Daegu	Dong-gu Sinam-dong
Korea, Republic of	Keimyung university dongsan medical center	Daegu	Jung-gu Dongsan-dong
Korea, Republic of	Kyungpook national university hospital	Daegu	Jung-gu Samdeok-dong
Korea, Republic of	Yeungnam university medical center	Daegu	Nam-gu Daemyeong-dong
Korea, Republic of	Dongguk university gyeongju hospital	Gyeongju	Seokjang-dong
Korea, Republic of	Gyeongsang national university hospital	Jinju	Chiram-dong

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean sitting Systolic Blood Pressure		After 12 weeks of treatment	No
Secondary	Mean Sitting Diastolic Blood Pressure		After 12 weeks of treatment	No
Secondary	echocardiography	Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity	After 12 weeks of treatment	No
Secondary	Blood Creatinine and Potssium level		After 4 and 12 weeks of treatment	Yes
Secondary	NYHA class		After 12 weeks of treatment	No