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

February 10, 2014
April 29, 2014
February 2014
June 2015   (final data collection date for primary outcome measure)
Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Change in sitting DBP at week 8 compared to baseline [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02059616 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in sitting SBP at week 4 and 8 [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  • Change in sitting DBP at week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving Δ sitting DBP > 10 mmHg and Δ sitting SBP < 20 mmHg after 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving sitting DBP < 90 mmHg and sitting SBP < 120 mmHg after 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Amlodipine 5mg
    Daily oral administration for 8 weeks
    Other Name: Norvasc 5mg
  • 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
  • Drug: Candesartan cilexetil 16mg
    Daily oral administration for 8 weeks
    Other Name: Atacand 16mg
  • Experimental: AML 5mg
    Amlodipine 5 mg, once a day for 8 weeks
    Intervention: Drug: Amlodipine 5mg
  • Experimental: AML 10mg
    Amlodipine 10 mg, once a day for 8 weeks
    Intervention: Drug: Amlodipine 10mg
  • Experimental: CC 8mg
    Candesartan Cilexetil 8 mg, once a day for 8 weeks
    Intervention: Drug: Candesartan Cilexetil 8mg
  • Experimental: CC 16mg
    Candesartan Cilexetil 16 mg, once a day for 8 weeks
    Intervention: Drug: Candesartan cilexetil 16mg
  • Experimental: AML 5mg/CC 8mg
    Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
    Interventions:
    • Drug: Amlodipine 5mg
    • Drug: Candesartan Cilexetil 8mg
  • Experimental: AML 5mg/CC16mg
    Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
    Interventions:
    • Drug: Amlodipine 5mg
    • Drug: Candesartan cilexetil 16mg
  • Experimental: AML 10mg/CC 8mg
    Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
    Interventions:
    • Drug: Amlodipine 10mg
    • Drug: Candesartan Cilexetil 8mg
  • Experimental: AML 10mg/CC 16mg
    Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
    Interventions:
    • Drug: Amlodipine 10mg
    • Drug: Candesartan cilexetil 16mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
384
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
No
Contact: Geun Seog Song, PhD 82-2-6740-2440 kssong1212@cj.net
Contact: Eun Ji Kim 82-2-6740-2443 keunji@cj.net
Korea, Republic of
 
NCT02059616
CJ_CCA_201
No
CJ HealthCare Corporation
CJ HealthCare Corporation
Not Provided
Principal Investigator: Seung-Jea Tahk Ajou University School of Medicine
CJ HealthCare Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP