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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by CJ HealthCare Corporation
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT02059616
First received: February 10, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
Drug: Amlodipine 5mg
Drug: Amlodipine 10mg
Drug: Candesartan Cilexetil 8mg
Drug: Candesartan cilexetil 16mg
Phase 2

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

Resource links provided by NLM:


Further study details as provided by CJ HealthCare Corporation:

Primary Outcome Measures:
  • Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8 [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  • Change in siDBP at week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 384
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AML 5mg
Amlodipine 5 mg, once a day for 8 weeks
Drug: Amlodipine 5mg
Daily oral administration for 8 weeks
Other Name: Norvasc 5mg
Experimental: AML 10mg
Amlodipine 10 mg, once a day for 8 weeks
Drug: Amlodipine 10mg
Daily oral administration for 8 weeks
Other Name: Norvasc 10mg
Experimental: CC 8mg
Candesartan Cilexetil 8 mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
Other Name: Atacand 8mg
Experimental: CC 16mg
Candesartan Cilexetil 16 mg, once a day for 8 weeks
Drug: Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Name: Atacand 16mg
Experimental: AML 5mg/CC 8mg
Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
Drug: Amlodipine 5mg
Daily oral administration for 8 weeks
Other Name: Norvasc 5mg
Drug: Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
Other Name: Atacand 8mg
Experimental: AML 5mg/CC16mg
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Drug: Amlodipine 5mg
Daily oral administration for 8 weeks
Other Name: Norvasc 5mg
Drug: Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Name: Atacand 16mg
Experimental: AML 10mg/CC 8mg
Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
Drug: Amlodipine 10mg
Daily oral administration for 8 weeks
Other Name: Norvasc 10mg
Drug: Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
Other Name: Atacand 8mg
Experimental: AML 10mg/CC 16mg
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Drug: Amlodipine 10mg
Daily oral administration for 8 weeks
Other Name: Norvasc 10mg
Drug: Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Name: Atacand 16mg

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059616

Contacts
Contact: Geun Seog Song, PhD 82-2-6740-2440 kssong1212@cj.net
Contact: Eun Ji Kim 82-2-6740-2443 keunji@cj.net

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Bundang, Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Konyang University Hospital Recruiting
Daejeon, Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Hallym University Sacred Heart hospital Recruiting
Kyungki-do, Korea, Republic of
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Inje University Haeundae Baik Hospital Recruiting
Pusan, Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Yonsei University Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Seoul St. Mary's hospital Recruiting
Seoul, Korea, Republic of
Seoul Medical Center Recruiting
Seoul, Korea, Republic of
Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Principal Investigator: Seung-Jea Tahk         
Wonju Severance Christian Hospital Recruiting
Wonju, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
Principal Investigator: Seung-Jea Tahk Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT02059616     History of Changes
Other Study ID Numbers: CJ_CCA_201
Study First Received: February 10, 2014
Last Updated: April 29, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 16, 2014