Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension

November 21, 2016 updated by: Shin Poong Pharmaceutical Co. Ltd.

A Multi-center, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy vs. Monotherapy of Candesartan and Amlodipine for Dose-Finding 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.
Completed

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 (Actual)

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.
392

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 Locations

  • Korea, Republic of
    • Bucheon
      • Wonmi-gu, Bucheon, Korea, Republic of
        • Catholic University of Korea Bucheon St. Mary's Hospital
    • Busan
      • Busanjin-gu, Busan, Korea, Republic of
        • Inje University Busan Paik Hospital
      • Seo-gu, Busan, Korea, Republic of
        • Pusan National University Hospital
    • Daegu
      • Joong-gu, Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Joong-gu, Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Nam- gu, Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
    • Goyang-si, Gyeoggi-do
      • Ilsandong-gu, Goyang-si, Gyeoggi-do, Korea, Republic of
        • Dongguk University Ilsan Hospital
    • Gwangju
      • Dong-Gu, Gwangju, Korea, Republic of
        • Chonnam National University Hospital
    • Gyeoggi-do
      • Uijeongbu-si, Gyeoggi-do, Korea, Republic of
        • Catholic University of Korea Uijeongbu St. Mary's Hospital
    • Incheon
      • Namdong-gu, Incheon, Korea, Republic of
        • Gachon University Gil Hospital
    • Jeollanam-do
      • Suncheon-si, Jeollanam-do, Korea, Republic of
        • St. Carollo General Hospital
    • Kangwon-Do
      • Wonju, Kangwon-Do, Korea, Republic of
        • Wonju Severance Christian Hospital
    • Seoul
      • Dongdaemun-gu, Seoul, Korea, Republic of
        • Catholic University of Korea St. Paul's Hospital
      • Dongdaemun-gu, Seoul, Korea, Republic of
        • Kyunghee University Medical Center
      • Gangdong-Gu, Seoul, Korea, Republic of
        • Kyung Hee University Hospital at Gangdong
      • Gangdong-gu, Seoul, Korea, Republic of
        • Hallym University Kangdong Sacred Heart Hospital
      • Gangdong-gu, Seoul, Korea, Republic of
        • VHS( Veterans Medical Service) Medical Center
      • Gwangjin-gu, Seoul, Korea, Republic of
        • Konkuk University Medical Center
      • Jongro-gu, Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seocho-Gu, Seoul, Korea, Republic of
        • Catholic University of Korea Seoul St. Mary's Hospital
      • Seongbuk-Gu, Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Yeongdeungpo-gu, Seoul, Korea, Republic of
        • Catholic University of Korea Yeouido St. Mary's Hospital
    • Ulsan
      • Dong-gu, Ulsan, Korea, Republic of
        • Ulsan University 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patients greater than or equal to 19 years of age
  2. Subject who was diagnosed with essential hypertension or after administer the antihypertensive drug (Subject who may temporarily suspend antihypertensive treatment based on doctor's decision)
  3. Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form

Exclusion Criteria:

  1. Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.
  2. Subject with difference of the blood pressure of over 20 mmHg for SBP or 10 mmHg for diastolic blood pressure (DSP) between three consecutive measurements in a selected arm during the screening visit
  3. Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
  4. Symptomatic orthostatic hypotension
  5. Severe heart failure( New York Heart Association(NYHA) Class III/IV)
  6. Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
  7. History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
  8. Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c > 9.0%)
  9. Subject with Haemodynamic disturbance, heart valve disease with structural defects
  10. Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
  11. Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
  12. Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  13. Chronic inflammatory disease requiring continuous anti-inflammatory treatment
  14. Clinically significant Renal or liver impairment, or laboratory abnormalities such as Ccr: below 30ml/min or Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 x Upper Limit Normal (ULN)
  15. Hypokalaemia(Serum potassium < 3.5 mmol/L) or hyperkalaemia(Serum potassium > 5.5 mmol/L)
  16. Subject with gastrointestinal disease(such as Crohn's disease, gastric ulcer, acute or chronic pancreatitis) or history of gastrointestinal surgery(not including appendectomy or hernia surgery) that might significantly alter the absorption of the drug
  17. history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)
  18. Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
  19. Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial
  20. history of malignant tumors within the past 5 years
  21. history of alcohol or drug abuse
  22. Pregnant women and lactating mothers

  23. Women who is planning to be pregnant during or 2 months after the study, or women or men who are not using medically acceptable methods of contraception *

    * progestin oral or implant contraceptive, intra-uterine device, condom, partner with surgical sterilization, etc.

  24. Use of other investigational products within the past 1 month
  25. Subject who are judged by the investigator unsuitable to participate in the study

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: Candesartan Cilexetil (CC) 8mg
Candesartan Cilexetil 8mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Other Names:
  • Atacand 8mg
Experimental: CC 16mg
Candesartan Cilexetil 16mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Other Names:
  • Atacand 16mg
Experimental: Amlodipine(AML) 5mg
Amlodipine 5mg, once a day for 8 weeks
Drug: Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Other Names:
  • Norvasc 5mg
Experimental: AML 10mg
Amlodipine 10mg, once a day for 8 weeks
Drug: Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Other Names:
  • Norvasc 10mg
Experimental: CC 8mg / AML 5mg
Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Other Names:
  • Atacand 8mg
Drug: Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Other Names:
  • Norvasc 5mg
Experimental: CC 8mg / AML 10mg
Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Other Names:
  • Atacand 8mg
Drug: Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Other Names:
  • Norvasc 10mg
Experimental: CC 16mg / AML 5mg
Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Other Names:
  • Atacand 16mg
Drug: Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Other Names:
  • Norvasc 5mg
Experimental: CC 16mg / AML 10mg
Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Other Names:
  • Atacand 16mg
Drug: Amlodipine 10mg
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 mean sitting Diastolic Blood Pressure (msDBP) 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
Measure Description
Time Frame
Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline
Time Frame: Week 4
Week 4
Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline
Time Frame: Week 4 and 8
Week 4 and 8
Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg
Time Frame: Week 4 and 8
Joint National Committee VII Guideline Treatment goal: < 140/90 mmHg (< 130/80 mmHg, diabetic or chronic renal failure patient)
Week 4 and 8
Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg
Time Frame: Week 4 and 8
Week 4 and 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.
Shin Poong Pharmaceutical Co. Ltd.

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.
  • Study Director: Chong-Jin Kim, Kyunghee University Hospital at Gangdong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 1, 2014

Primary Completion (Actual)

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.
December 1, 2015

Study Completion (Actual)

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).
October 24, 2016

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.
October 24, 2016

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.
October 26, 2016

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.
November 22, 2016

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.
November 21, 2016

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.
November 1, 2016

More Information

Terms related to this study

Keywords

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.
  • SP-AC-002

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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