Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

NCT ID: NCT02651870

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-22
• Study Completion Date: 2016-02-29

Brief Summary

A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Candesartan 16mg + Amlodipine 5mg

Candesartan 16mg + Amlodipine 5mg, po, q.d.

Group Type: EXPERIMENTAL

Candesartan 16mg

Intervention Type: DRUG

Amlodipine 5mg

Intervention Type: DRUG

Candesartan 16mg + Amlodipine 10mg

Candesartan 16mg + Amlodipine 10mg, po, q.d.

Group Type: EXPERIMENTAL

Candesartan 16mg

Intervention Type: DRUG

Amlodipine 10mg

Intervention Type: DRUG

Candesartan 16mg

Candesartan 16mg, po, q.d.

Group Type: ACTIVE_COMPARATOR

Candesartan 16mg

Intervention Type: DRUG

Interventions

Candesartan 16mg

Intervention Type: DRUG

Amlodipine 5mg

Intervention Type: DRUG

Amlodipine 10mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age of 19 or above
• Inadequately controlled Essential hypertension at Screening

1. Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1

• Mean sitDBP ≥ 95mmHg on target arm

2. Taking antihypertensive drug but not controlled

• Mean sitDBP ≥ 90mmHg on target arm
• Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy

• Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
• Ability to provide written informed consent

Exclusion Criteria

• The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
• Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
• Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
• Patient with congestive heart failure(NYHA class III, IV)
• Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
• History of stroke, cerebral hemorrhage within 6 months
• Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c > 8.5%
• History of severe or malignant retinopathy
• AST/ALT > UNL*3, Serum creatinine > UNL*1.5, K > 5.5mEq/L
• Patient with acute or chronic inflammatory(treatment required) status
• Patient who need to take antihypertensive drug besides Investigational products
• Patient must be treated with medications prohibited for concomitant use during the study period
• History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
• Hypersensitive to Candesartan/Amlodipine
• Patient who are dependent on drugs or alcohol within 6 months
• History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
• Patients treated with other investigational product within 30 days at first time taking the investigational product
• Women with pregnant, breast-feeding
• History of malignant tumor within 5 years
• Not eligible to participate for the study at the discretion of investigator

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

144HT14020

Identifier Type: -

Identifier Source: org_study_id