NCT01682564

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Congestive Heart Failure

Interventions

Type	Name	Description
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)
DRUG	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)

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-09-11
• Last updated: 2015-09-24

Locations

14 sites across 1 country: South Korea