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S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-amlodipine 2.5mg + Chlorthalidone 25mg
S-amlodipine 2.5mg + Telmisartan 40mg
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women with essential hypertension who were aged 19 years or older and younger than 80 years
  2. Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening)
  3. Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg
  4. Those who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

  1. Patients with a history of secondary hypertension and all those with suspected secondary hypertension (including, but not limited to, coarctation of the aorta, primary aldosteronism, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.)
  2. Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1.
  3. When the blood pressure was measured three times in the reference arm of visit 1 (screening), the difference between the highest lowest sit SBP was 20 mmHg or higher and the difference between the highest lowest sit DBP was 10 mmHg or higher.
  4. An uncontrolled diabetic patient(HbA1c≥9.0%)
  5. In addition to antihypertensive drugs, drugs that may affect blood pressure( Systemic steroids, Thyroid hormones, Oral contraceptives, antipsychotic drugs, NSAIDs, sympathomimetics, immunosuppressants, etc.) have been continuously administered for more than 12 weeks prior to visit 1 (screening)
  6. Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial
  7. Patients with orthostatic hypotension with symptoms
  8. Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years
  9. Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus
  10. Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug
  11. Patients with clinically significant renal • hepatic disease such as those on dialysis, cirrhosis, biliary obstruction, hepatic failure, or those who have the following findings on visit 1 (screening)

    • ALanine Transaminase or ASpartate Transaminase is more than 3 times the normal upper limit
    • Total bilirubin more than twice the normal upper limit
    • More than twice the Blood Urea Nitrogen normal upper limit
    • Alkaline Phosphatase More than twice the normal upper limit - Creatinine Clearance Less than 10 mL / min
  12. Within the last 6 months, patients who have received the following diseases or treatments and whose clinical judgment is meaningful to the researcher

    • Severe heart disease (heart failure New York Heart Association class III and IV), ischemic heart disease, peripheral vascular disease, hemodynamically significant valve stenosis, arrhythmia, etc
    • Patients with severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.)
  13. Shock patient
  14. Patients with clinical history of alcohol or substance abuse
  15. Patients with potential pregnancy or breastfeeding

    • In the case of pregnant women, if the negative is not confirmed during pregnancy test
    • Women who did not consent to contraception in a medically acceptable way during the trial
    • Medically acceptable contraceptive methods: use condoms, injectable or injectable contraceptives, intrauterine contraceptive device, etc.
  16. If the tester judges that the participation in the clinical trial is not legal or mental character
  17. Clinical studies with other clinical trial drugs within 4 weeks prior to screening patients with experience

Sites / Locations

  • Hallym University Medical CenterRecruiting
  • Kyung Hee University HospitalRecruiting
  • Hallym University Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Korea Univ. Guro HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Hanyang University Medical CenterRecruiting
  • Asan Medical CenterRecruiting
  • Ajou Univ. Medical CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S-amlodipine + Chlorthalidone

S-amlodipine + Telmisartan

Arm Description

patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.

patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.

Outcomes

Primary Outcome Measures

sit diastolic blood pressure
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.

Secondary Outcome Measures

sit diastolic blood pressure
Mean change in sit diastolic blood pressure after 6 weeks compared to baseline.
sit systolic blood pressure
Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline.
Blood pressure normalization
Blood pressure normalization ratio after 12 weeks compared to baseline( sit systolic blood pressure <140 mmHg or sit diastolic blood pressure <90 mmHg).

Full Information

First Posted
July 17, 2017
Last Updated
July 20, 2017
Sponsor
Seoul National University Bundang Hospital
Collaborators
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03226340
Brief Title
S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
Official Title
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With Calcium Channel Blocker Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
March 31, 2018 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Hanlim Pharm. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With CCB(Calcium Channel Blocker) Monotherapy
Detailed Description
The aim of this study is to verify the difference at week 12 from the baseline value in the average variation of diastolic blood pressure (sitDBP) of the study group in which S-amlodipine / Chlorthalidone combination therapy is to be used in patients with essential hypertension who did not adequately respond to monotherapy of amlodipine or S-amlodipine, compared to the control group, in which a combination therapy of S-amlodipine / telmisartan is to be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-amlodipine + Chlorthalidone
Arm Type
Experimental
Arm Description
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
Arm Title
S-amlodipine + Telmisartan
Arm Type
Active Comparator
Arm Description
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
S-amlodipine 2.5mg + Chlorthalidone 25mg
Intervention Description
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
S-amlodipine 2.5mg + Telmisartan 40mg
Intervention Description
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
Primary Outcome Measure Information:
Title
sit diastolic blood pressure
Description
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
sit diastolic blood pressure
Description
Mean change in sit diastolic blood pressure after 6 weeks compared to baseline.
Time Frame
6 weeks
Title
sit systolic blood pressure
Description
Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline.
Time Frame
12 weeks
Title
Blood pressure normalization
Description
Blood pressure normalization ratio after 12 weeks compared to baseline( sit systolic blood pressure <140 mmHg or sit diastolic blood pressure <90 mmHg).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women with essential hypertension who were aged 19 years or older and younger than 80 years Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening) Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg Those who have voluntarily agreed in writing to participate in the trial Exclusion Criteria: Patients with a history of secondary hypertension and all those with suspected secondary hypertension (including, but not limited to, coarctation of the aorta, primary aldosteronism, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.) Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1. When the blood pressure was measured three times in the reference arm of visit 1 (screening), the difference between the highest lowest sit SBP was 20 mmHg or higher and the difference between the highest lowest sit DBP was 10 mmHg or higher. An uncontrolled diabetic patient(HbA1c≥9.0%) In addition to antihypertensive drugs, drugs that may affect blood pressure( Systemic steroids, Thyroid hormones, Oral contraceptives, antipsychotic drugs, NSAIDs, sympathomimetics, immunosuppressants, etc.) have been continuously administered for more than 12 weeks prior to visit 1 (screening) Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial Patients with orthostatic hypotension with symptoms Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug Patients with clinically significant renal • hepatic disease such as those on dialysis, cirrhosis, biliary obstruction, hepatic failure, or those who have the following findings on visit 1 (screening) ALanine Transaminase or ASpartate Transaminase is more than 3 times the normal upper limit Total bilirubin more than twice the normal upper limit More than twice the Blood Urea Nitrogen normal upper limit Alkaline Phosphatase More than twice the normal upper limit - Creatinine Clearance Less than 10 mL / min Within the last 6 months, patients who have received the following diseases or treatments and whose clinical judgment is meaningful to the researcher Severe heart disease (heart failure New York Heart Association class III and IV), ischemic heart disease, peripheral vascular disease, hemodynamically significant valve stenosis, arrhythmia, etc Patients with severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.) Shock patient Patients with clinical history of alcohol or substance abuse Patients with potential pregnancy or breastfeeding In the case of pregnant women, if the negative is not confirmed during pregnancy test Women who did not consent to contraception in a medically acceptable way during the trial Medically acceptable contraceptive methods: use condoms, injectable or injectable contraceptives, intrauterine contraceptive device, etc. If the tester judges that the participation in the clinical trial is not legal or mental character Clinical studies with other clinical trial drugs within 4 weeks prior to screening patients with experience
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
State/Province
Dongan-gu
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jo
Phone
82-31-380-3722
Email
sophi5neo@gmail.com
Facility Name
Kyung Hee University Hospital
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Joong Kim
Phone
82-2-958-8180
Email
soojoong@dreamwiz.com
Facility Name
Hallym University Medical Center
City
Seoul
State/Province
Gangdong-gu,
ZIP/Postal Code
05355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyoo-Rok Han
Phone
82-2-2224-2405
Email
krheart@hallym.or.kr
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park
Phone
82-2-3410-0887
Email
tyche.park@gmail.com
Facility Name
Korea Univ. Guro Hospital
City
Seoul
State/Province
Guro
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eung-ju Kim, MD,PhD
Phone
82-8-2626-3022
Email
withnoel@empas.com
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Jai Cho
Phone
82-2-2072-3931
Email
hyunjaicho@snu.ac.kr
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Seongdong-gu
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Ho Shin
Phone
82-2-2290-8308
Email
jhs2003@hanyang.ac.kr
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Min Song
Phone
82-2-3010-3158
Email
jmsong@amc.seoul.kr
Facility Name
Ajou Univ. Medical Center
City
Suwon-si
State/Province
Yeong-tong
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-han Shin, MD,PhD
Phone
82-31-219-5710
Email
shinjh@ajou.ac.kr
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
Phone
82-31-787-7007
Email
djchoi@snubh.org
First Name & Middle Initial & Last Name & Degree
Jin Joo Park, MD
Phone
82-31-787
Ext
7074
Email
jinjooparkmd@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29925421
Citation
Jo SH, Park SJ, Kim EJ, Kim SJ, Cho HJ, Song JM, Shin J, Park JJ, Shin JH, Han KR, Choi DJ. S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial. Trials. 2018 Jun 20;19(1):324. doi: 10.1186/s13063-018-2636-1.
Results Reference
derived

Learn more about this trial

S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension

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