Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
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
1 other identifier
interventional
392
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedNovember 22, 2016
November 1, 2016
1.2 years
October 24, 2016
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline
Week 8
Secondary Outcomes (4)
Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline
Week 4
Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline
Week 4 and 8
Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg
Week 4 and 8
Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg
Week 4 and 8
Study Arms (8)
Candesartan Cilexetil (CC) 8mg
EXPERIMENTALCandesartan Cilexetil 8mg, once a day for 8 weeks
CC 16mg
EXPERIMENTALCandesartan Cilexetil 16mg, once a day for 8 weeks
Amlodipine(AML) 5mg
EXPERIMENTALAmlodipine 5mg, once a day for 8 weeks
AML 10mg
EXPERIMENTALAmlodipine 10mg, once a day for 8 weeks
CC 8mg / AML 5mg
EXPERIMENTALCandesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
CC 8mg / AML 10mg
EXPERIMENTALCandesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
CC 16mg / AML 5mg
EXPERIMENTALCandesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
CC 16mg / AML 10mg
EXPERIMENTALCandesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
Interventions
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine 5mg Daily oral administration for 8 weeks
Amlodipine 10mg Daily oral administration for 8 weeks
Eligibility Criteria
You may qualify if:
- Male or female patients greater than or equal to 19 years of age
- 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)
- Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form
You may not qualify if:
- Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.
- 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
- Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
- Symptomatic orthostatic hypotension
- Severe heart failure( New York Heart Association(NYHA) Class III/IV)
- Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
- History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
- Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c \> 9.0%)
- Subject with Haemodynamic disturbance, heart valve disease with structural defects
- Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
- Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
- Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Chronic inflammatory disease requiring continuous anti-inflammatory treatment
- 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)
- Hypokalaemia(Serum potassium \< 3.5 mmol/L) or hyperkalaemia(Serum potassium \> 5.5 mmol/L)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Catholic University of Korea Bucheon St. Mary's Hospital
Wonmi-gu, Bucheon, South Korea
Inje University Busan Paik Hospital
Busanjin-gu, Busan, South Korea
Pusan National University Hospital
Seo-gu, Busan, South Korea
Keimyung University Dongsan Medical Center
Joong-gu, Daegu, South Korea
Kyungpook National University Hospital
Joong-gu, Daegu, South Korea
Daegu Catholic University Medical Center
Nam- Gu, Daegu, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Dongguk University Ilsan Hospital
Ilsandong-gu, Goyang-si, Gyeoggi-do, South Korea
Chonnam National University Hospital
Dong-Gu, Gwangju, South Korea
Catholic University of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, Gyeoggi-do, South Korea
Gachon University Gil Hospital
Namdong-gu, Incheon, South Korea
St. Carollo General Hospital
Suncheon-si, Jeollanam-do, South Korea
Catholic University of Korea St. Paul's Hospital
Dongdaemun-gu, Seoul, South Korea
KyungHee University Medical Center
Dongdaemun-gu, Seoul, South Korea
Hallym University Kangdong Sacred Heart Hospital
Gangdong-gu, Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Gangdong-Gu, Seoul, South Korea
VHS( Veterans Medical Service) Medical Center
Gangdong-gu, Seoul, South Korea
Konkuk University Medical Center
Gwangjin-gu, Seoul, South Korea
Seoul National University Hospital
Jongro-gu, Seoul, South Korea
Catholic University of Korea Seoul St. Mary's Hospital
Seocho-Gu, Seoul, South Korea
Korea University Anam Hospital
Seongbuk-Gu, Seoul, South Korea
Catholic University of Korea Yeouido St. Mary's Hospital
Yeongdeungpo-gu, Seoul, South Korea
Ulsan University Hospital
Dong-gu, Ulsan, South Korea
Related Publications (1)
Sohn IS, Kim CJ, Ahn T, Youn HJ, Jeon HK, Ihm SH, Cho EJ, Chung WB, Chae SC, Kim WS, Nam CW, Park SM, Choi JY, Kim YK, Hong TJ, Lee HY, Cho JH, Shin ES, Yoon JH, Yang TH, Jeong MH, Lee JH, Park JI. Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial. Clin Ther. 2017 Aug;39(8):1628-1638. doi: 10.1016/j.clinthera.2017.06.014. Epub 2017 Jul 19.
PMID: 28734660DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chong-Jin Kim
KyungHee University Hospital at Gangdong
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 22, 2016
Record last verified: 2016-11