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

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Candesartan 16mg; Drug: Amlodipine 5mg; Drug: Amlodipine 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02651870

144HT14020

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Candesartan 16mg + Amlodipine 5mg

Experimental group

Description:

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

Treatment:

Drug: Amlodipine 5mg

Drug: Candesartan 16mg

Candesartan 16mg + Amlodipine 10mg

Experimental group

Description:

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

Treatment:

Drug: Candesartan 16mg

Drug: Amlodipine 10mg

Candesartan 16mg

Active Comparator group

Description:

Candesartan 16mg, po, q.d.

Treatment:

Drug: Candesartan 16mg