A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, PhaseⅡ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Candesartan Cilexetil and Amlodipine Besylate for the Dose Selection in Patients With Essential Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059616
• Other study ID #: CJ_CCA_201
• Status: Recruiting
• Phase: Phase 2
• First received: February 10, 2014
• Last updated: April 29, 2014
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: CJ HealthCare Corporation
• Contact: Geun Seog Song, PhD
• Phone: 82-2-6740-2440
• Email: kssong1212[@]cj.net
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female aged = 19 and = 75 years old

• Subject with mild-to-moderate uncomplicated 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

Exclusion Criteria:

• Subject with severe hypertension (siDBP = 115 mmHg or siSBP = 185 mmHg)

• Subject with difference in the mean blood pressure of over 10mmHg for siDBP or 20mmHg 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 hypertension, adrenal medullary and cortical hyperfunction, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, 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 supine position)

• Subject with Type 1 diabetes mellitus OR Type 2 diabetes mellitus with poor glucose control (defined as subject on insulin 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 III-IV), ischemic heart disease within the past 6 months (unstable angina, myocardial infarction), peripheral vascular 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 severe cerebrovascular disease (history of stroke, cerebral infarction, or cerebral hemorrhage within the past 6 months)

• Subject with or with a history of wasting disease, autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus), 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 the following clinically significant laboratory abnormalities:

• AST or ALT > 3 x Upper Limit Normal (ULN)

• Serum Creatinine > 1.5 ULN

• Serum potassium < 3.5 mmol/L or > 5.5 mmol/L

• Subject with any surgical or medical condition of the gastrointestinal tract that might significantly 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 years (except for localized basal cell carcinoma of the skin)

• Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy

• Subject with chronic kidney disease on dialysis

• Subject with cardiogenic shock

• Subject requiring concomitant use of other antihypertensive or contraindicated drugs during the entire study period

• Subject with known or suspected contraindications, including history of allergy or hypersensitivity to ARB or dihydropyridine derivatives

• Subject who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARB

• Pregnant women, lactating mothers, women suspected of being pregnant, women who wish to be pregnant during the study, or women of child-bearing potential who are not using medically acceptable methods of contraception (oral contraceptive, intra-uterine device, condom, etc.), except for women with surgical sterilization. Pre-menopausal women who are not surgically sterilized must have a negative pregnancy test result at Visit 1 and maintain acceptable methods of contraception throughout the study. Periodic abstinence (eg, symptothermal, calendar, post-ovulation methods), or hormonal contraceptive are not acceptable methods of contraception

• History of drug or alcohol abuse within the past 1 year

• Use of other investigational products within the past 4 weeks

• Subject who are judged unsuitable to participate in the study in the opinion of the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Amlodipine 5mg
Daily oral administration for 8 weeks
• Amlodipine 10mg
Daily oral administration for 8 weeks
• Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
• Candesartan cilexetil 16mg
Daily oral administration for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Bundang
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Hallym University Sacred Heart hospital	Kyungki-do
Korea, Republic of	Inje University Haeundae Baik Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline		Week 8	No
Secondary	Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8		Week 4 and 8	No
Secondary	Change in siDBP at week 4		Week 4	No
Secondary	Proportion of patients achieving ?siDBP > 10 mmHg and ?siSBP < 20 mmHg after 8 weeks		Week 8	No
Secondary	Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks		Week 8	No