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

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ClinicalTrials.gov Identifier: NCT02944734
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Shin Poong Pharmaceutical Co. Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Candesartan Cilexetil 8mg Drug: Candesartan Cilexetil 16mg Drug: Amlodipine 5mg Drug: Amlodipine 10mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Atacand 8mg

Drug: Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Other Name: 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 Name: Atacand 8mg

Drug: Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Other Name: 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 Name: Atacand 16mg

Drug: Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Other Name: 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 Name: Atacand 16mg

Drug: Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Other Name: Norvasc 10mg




Primary Outcome Measures :
  1. Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline [ Time Frame: Week 4 ]
  2. Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline [ Time Frame: Week 4 and 8 ]
  3. 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)

  4. Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg [ Time Frame: Week 4 and 8 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944734


Locations
Korea, Republic of
Catholic University of Korea Bucheon St. Mary's Hospital
Wonmi-gu, Bucheon, Korea, Republic of
Inje University Busan Paik Hospital
Busanjin-gu, Busan, Korea, Republic of
Pusan National University Hospital
Seo-gu, Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
Joong-gu, Daegu, Korea, Republic of
Kyungpook National University Hospital
Joong-gu, Daegu, Korea, Republic of
Daegu Catholic University Medical Center
Nam- gu, Daegu, Korea, Republic of
Dongguk University Ilsan Hospital
Ilsandong-gu, Goyang-si, Gyeoggi-do, Korea, Republic of
Chonnam National University Hospital
Dong-Gu, Gwangju, Korea, Republic of
Catholic University of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, Gyeoggi-do, Korea, Republic of
Gachon University Gil Hospital
Namdong-gu, Incheon, Korea, Republic of
St. Carollo General Hospital
Suncheon-si, Jeollanam-do, Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Kangwon-Do, Korea, Republic of
Catholic University of Korea St. Paul's Hospital
Dongdaemun-gu, Seoul, Korea, Republic of
KyungHee University Medical Center
Dongdaemun-gu, Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
Gangdong-gu, Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
Gangdong-Gu, Seoul, Korea, Republic of
VHS( Veterans Medical Service) Medical Center
Gangdong-gu, Seoul, Korea, Republic of
Konkuk University Medical Center
Gwangjin-gu, Seoul, Korea, Republic of
Seoul National University Hospital
Jongro-gu, Seoul, Korea, Republic of
Catholic University of Korea Seoul St. Mary's Hospital
Seocho-Gu, Seoul, Korea, Republic of
Korea University Anam Hospital
Seongbuk-Gu, Seoul, Korea, Republic of
Catholic University of Korea Yeouido St. Mary's Hospital
Yeongdeungpo-gu, Seoul, Korea, Republic of
Ulsan University Hospital
Dong-gu, Ulsan, Korea, Republic of
Sponsors and Collaborators
Shin Poong Pharmaceutical Co. Ltd.
Investigators
Study Director: Chong-Jin Kim KyungHee University Hospital at Gangdong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shin Poong Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02944734     History of Changes
Other Study ID Numbers: SP-AC-002
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Shin Poong Pharmaceutical Co. Ltd.:
Candesartan
Amlodipine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Calcium Channel Blockers

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