A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy

NCT02368652 | Completed Phase 3

• 1 other identifier: CJ_CCA_301A
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 19

Brief Summary

Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination therapy on patients of essential hypertension who are not properly controlled by candesartan cilexetil monotherapy.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline

  Week 8

Secondary Outcomes (4)

• Change in siDBP at week 4

  Week 4

• Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8

  Week 4 and 8

• Proportion of patients achieving ΔsiDBP ≥ 10 mmHg and ΔsiSBP ≥ 20 mmHg after 8 weeks

  Week 8

• Proportion of patients achieving siDBP < 90 mmHg and siSBP < 140 mmHg after 8 weeks

  Week 8

Study Arms (2)

CC 16mg

EXPERIMENTAL

Candesartan ceilexetil 16mg, once a day for 8 weeks

Drug: Candesartan cilexetil 16mg

AML 10mg / CC 16mg

EXPERIMENTAL

Amlodipine 10mg and Candesartan ceilexetil 16mg, once a day for 8 weeks

Drug: Amlodipine 10mg, Candesartan cilexetil 16mg

Interventions

Candesartan cilexetil 16mg DRUG

Daily oral administration for 8 weeks

Also known as: Atacand 16mg

CC 16mg

Amlodipine 10mg, Candesartan cilexetil 16mg DRUG

Daily oral administration for 8 weeks

Also known as: Norvasc 10mg, Atacand 16mg

AML 10mg / CC 16mg

Eligibility Criteria

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

You may qualify if:

• Male or female aged ≥ 19 and ≤ 75 years old
• Subject with essential hypertension
• Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial

You may not qualify if:

• Subject who is siDBP ≥ 120 mmHg or siSBP ≥ 200 mmHg at Visit 1 (screening)
• Subject with difference in the mean blood pressure of over 10 mmHg for siDBP or 20 mmHg for siSBP between both arms at the screening visit
• Subject with known or suspected secondary hypertension \[Including but not limited to any of the following: renovascular diseases, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.\]
• Subject with symptomatic orthostatic hypotension(a sudden fall in siDBP of at least 10 mmHg or siSBP of at least 20 mmHg after standing compared with blood pressure from the sitting or supin position)
• Subject with type 1 or type 2 diabetes mellitus with poor glucose control (defined as subject on inculin treatment, with HbA1c \> 9.0% or with a modification in the oral anti-hyperglycemic medication regiment within the past 12 weeks prior to visit 1)
• Subject with severe heart disease(congestive heart failure(NYHA class 3 or 4), ischemic heart disease within the past 6 months(unstable angina, myocardial infarction), peripheral blood vascula disease, history of Percutaneous Transluminal Coronary Angioplasty or coronary artery bypass grafting)
• Subject with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia
• Subject with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve
• Subject with cardiogenic shock
• Subject with severe cerebrovascular disease (history of stroke, cerebral infraction, or cerebral hemorrhage within the past 6 months)
• Subject with a history of or ongoing wasting disease, autoimmune diseases(rheumatoid arthritis, systemic lupus erythematosus, etc.) or connective tissue disease
• Subject with known moderate or malignant retinopathy (history of retinal signs of hemorrhage, visual impairment, retinal microaneurysm etc. within the past 6 months)
• Subject with any surgical or medical condition of the gastrointestinal tract that might sugnificantly alter the absorption, distribution, metabolism or excretion of the drug
• Subject with a history of malignant tumors including leukemia and lymphoma within the past 5 yesrs(except for localized basal cell carcinoma of the skin)
• Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (19)

Hallym University Sungsim Hospital

Anyang-si, South Korea

Location

Inje University Busan Baik Hospital

Busan, South Korea

Location

Inje University Haeundae Baik Hospital

Busan, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Inje University Ilsan Baik Hospital

Ilsan, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Gangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital Catholic University

Seoul, South Korea

Location

Soonchunhyang University Hospital

Seoul, South Korea

Location

Yonsei University Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

candesartan cilexetil; Amlodipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Seungjae Tahk

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: February 16, 2015
• First Posted: February 23, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

KR (19)