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

April 29, 2014 updated by: HK inno.N Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Eun Ji Kim
  • Phone Number: 82-2-6740-2443
  • Email: keunji@cj.net

Study Locations

  • Korea, Republic of
      • Bundang, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Busan, Korea, Republic of
        • Recruiting
        • Dong-A University Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of
        • Recruiting
        • Konyang University Hospital
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
      • Ilsan, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
      • Kyungki-do, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
      • Pusan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Recruiting
        • Inje University Haeundae Baik Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Gangnam Severance Hospital
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • Seung-Jea Tahk
      • Wonju, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AML 5mg
Amlodipine 5 mg, once a day for 8 weeks
Drug: Amlodipine 5mg
Daily oral administration for 8 weeks
Other Names:
  • Norvasc 5mg
Experimental: AML 10mg
Amlodipine 10 mg, once a day for 8 weeks
Drug: Amlodipine 10mg
Daily oral administration for 8 weeks
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Norvasc 5mg
Drug: Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
Other Names:
  • Atacand 8mg
Experimental: AML 5mg/CC16mg
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Drug: Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Names:
  • Atacand 16mg
Drug: Amlodipine 5mg
Daily oral administration for 8 weeks
Other Names:
  • Norvasc 5mg
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 Names:
  • Norvasc 10mg
Drug: Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
Other Names:
  • Atacand 8mg
Experimental: AML 10mg/CC 16mg
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Drug: Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Names:
  • Atacand 16mg
Drug: Amlodipine 10mg
Daily oral administration for 8 weeks
Other Names:
  • Norvasc 10mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in siDBP at week 4
Time Frame: Week 4
Week 4
Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8
Time Frame: Week 4 and 8
Week 4 and 8
Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks
Time Frame: Week 8
Week 8
Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HK inno.N Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Jea Tahk, Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CJ_CCA_201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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