Study to Confirm the Efficacy and Safety of Fixed-dose Combinations of Amlodipine and Candesartan

NCT03231982 | Unknown Phase 4

• 1 other identifier: CJ_CCA_401
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil administered in a fixed-dose combination tablet versus co-administered as their separate formulations in patients with essential hypertension who have shown inadequate response on monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately controlled by co-administration of amlodipine besylate and candesartan cilexetil single agents

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment

  For change in siSBP from baseline after 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm. The LS mean change in siSBP from baseline after 8 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 8 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.

  Week 8

Secondary Outcomes (3)

• Change in siSBP from baseline after 4 weeks of treatment

  Week 4

• Change in siDBP from baseline after 4 and 8 weeks of treatment

  Week 4 and Week 8

• Proportion of subjects with siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment

  Week8

Other Outcomes (3)

• Adverse events

  Baseline, Week 4 and Week 8

• Clinical laboratory tests

  Baseline, Wee4 and Week 8

• Electrocardiogram (ECG)

  Screening and Week 8

Study Arms (2)

Group I

EXPERIMENTAL

Fixed-Dose combination of Candesartan cilexetil 8mg and Amlodipine 5mg(or Fixed-Dose combination of Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks

Drug: Group I

Group II

ACTIVE COMPARATOR

Candesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks

Drug: Group II

Interventions

Group I DRUG

Machkhan Tab. 8/5 mg + Atacan Tab. 8 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks or Machkhan Tab. 16/5 mg + Atacan Tab. 16 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks

Also known as: Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)

Group I

Group II DRUG

Atacan Tab. 8 mg + Norvasc Tab. 5 mg + Machkhan Tab.8/5 mg placebo for 8 weeks or Atacan Tab. 16 mg + Norvasc Tab. 5 mg + Machkhan Tab.16/5 mg placebo for 8 weeks

Also known as: Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mg

Group II

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female aged 19 to 75 years
• Diagnosed with essential hypertension
• Patients with essential hypertension who have shown inadequate response (mean siSBP ≥ 140 mmHg or mean siDBP ≥ 90 mmHg) to treatment with amlodipine or candesartan cilexetil.
• Patients with essential hypertension with blood pressure adequately controlled by co-administration of amlodipine besylate and candesartan cilexetil (mean siSBP \< 140 mmHg and mean siDBP \< 90 mmHg).
• Voluntarily consented to participate in the study and signed the informed consent form after receiving the explanation of the objectives, methods and effects of the study.

You may not qualify if:

• The difference in blood pressure between the selected arm versus non-selected arm is ≥ 20 mmHg for siSBP and ≥ 10 mmHg for siDBP at Visit 1 (screening).
• Blood pressure taken at screening and randomization is ≥ 180 mmHg for siSBP or ≥ 110 mmHg for siDBP.
• Diagnosed with secondary hypertension or suspected of secondary hypertension \[e.g., renovascular disease, adrenal medullary and cortical hyperfunction, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.\]
• Patients with symptomatic orthostatic hypertension (the difference in the blood pressures between measured at supine position and measured at standing position is ≥ 20 mmHg for siSBP and ≥ 10 mmHg for siDBP)
• Diagnosis of type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin therapy or with HbA1c \> 9%)
• Patients with severe cardiac conditions: heart failure (NYHA Class 3 or 4), history of ischemic cardiac disease (unstable angina, myocardial infarction), peripheral vascular diseases, percutaneous transluminal angioplasty or coronary artery bypass graft within recent 6 months.
• Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia at the discretion of the investigator
• Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve stenosis
• History of cardiogenic shock
• Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral infarction or cerebral hemorrhage within recent 6 months)
• History or current evidence of wasting, autoimmune (such as rheumatoid arthritis and systemic lupus erythematosus) or connective tissue diseases
• Known diagnosis of moderate or malignant retinopathy (including retinal hemorrhage, visual disturbance and retinal microaneurysm within 6 months)
• Patients with surgical or medical intestinal diseases or having received surgeries that could interfere with drug absorption distribution, metabolism and elimination
• History of malignancy including leukemia and lymphoma within recent 5 years except for localized basal cell carcinoma of the skin)
• Patients with any inflammatory diseases requiring chronic anti-inflammatory therapy

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Yonsei University Severance Cardiovascular Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

SangJun Youn, Ph.D.

CONTACT

82-8-6477-0240; sangjun.youn@cj.net

ChungHyun Choi, MS

CONTACT

82-8-6477-0236; chunghyun.choi@cj.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: April 17, 2017
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)