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Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telminuvo®Tab. 40/2.5mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, Telmisartan/S-Amlodipine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. More than 20 years in hypertension patient

  2. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening

    • Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg.
    • Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg.

  3. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization

    • Clinic Mean sitting diastolic blood pressure ≥ 90mmHg
  4. Patient who decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

  1. Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization
  2. As night workers who sleep during the day and whose working hours including 00:00 to 04:00
  3. Secondary Hypertension
  4. Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months
  5. Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
  6. type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c > 8.0%)
  7. Severe or malignant retinopathy

  8. Abnormal laboratory test results

    • Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 2
    • Serum creatinine > Upper normal limit X 2
  9. Acute of chronic inflammatory status requiring treatment
  10. Need for other antihypertensive drugs during the trial
  11. Need for prohibited medication specified in the protocol
  12. A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
  13. Severe hypersensitivity to amlodipine or telmisartan
  14. History of drug or alcohol abuse within 6 months

  15. Surgical or medical conditions

    • History of major gastrointestinal surgery
    • History of active inflammatory bowel syndrome within 12 months
    • Abnormal pancreatic functions
    • Gastrointestinal/rectal bleeding
    • Urinary tract obstruction
  16. Administration of other Investigational Product within 30 days
  17. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
  18. History of malignant tumor within 5 years (including leukemia and lymphoma)
  19. Another clinical condition in investigator's judgement

Sites / Locations

  • Korean University Guro HospitalRecruiting
  • Myongji HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Bundang Jesaeng HospitalRecruiting
  • Daegu Catholic University Medical CenterRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Cheju Halla General HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Pusan National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

night

morning

Arm Description

Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg

Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg

Outcomes

Primary Outcome Measures

Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.

Secondary Outcome Measures

Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8
Daytime: 06:00~21:59 Nighttime: 22:00~05:59 Morning: 06:00~11:59
Change from baseline in the clinic mean blood pressure at week 8.
24hr ABPM and Clinic BP control at week 8.
<24hr ABPM> 24hr mean BP: 24hr mean Systolic blood pressure(SBP)<130mmHg and 24hr mean Diastolic blood pressure(DBP)<80mmHg Daytime BP: Daytime mean SBP<135mmHg and Daytime mean DBP<85mmHg Night time BP: Night time mean SBP<120mmHg and Night time mean DBP<70mmHg <Clinic BP> : Mean sitting systolic blood pressure<140mmHg and Mean sitting diastolic blood pressure<90mmHg
Morning BP Surge
The morning BP surge was calculated as the morning BP minus the lowest BP. Morning BP was defined as the average BP during the first 2 h after waking. The lowest BP was defined as the average of three BP readings focused on the lowest night-time reading (that is, the lowest reading plus the readings immediately before and after)

Full Information

First Posted
August 17, 2015
Last Updated
August 18, 2017
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02526875
Brief Title
Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
Official Title
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Detailed Description
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, Telmisartan/S-Amlodipine

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
night
Arm Type
Experimental
Arm Description
Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Arm Title
morning
Arm Type
Active Comparator
Arm Description
Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Intervention Type
Drug
Intervention Name(s)
Telminuvo®Tab. 40/2.5mg
Other Intervention Name(s)
Telmisartan/S-Amlodipine 40/2.5mg
Intervention Description
per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Primary Outcome Measure Information:
Title
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Description
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Time Frame
Baseline and week 8
Secondary Outcome Measure Information:
Title
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8
Description
Daytime: 06:00~21:59 Nighttime: 22:00~05:59 Morning: 06:00~11:59
Time Frame
Baseline and week 8
Title
Change from baseline in the clinic mean blood pressure at week 8.
Time Frame
Baseline and week 8
Title
24hr ABPM and Clinic BP control at week 8.
Description
<24hr ABPM> 24hr mean BP: 24hr mean Systolic blood pressure(SBP)<130mmHg and 24hr mean Diastolic blood pressure(DBP)<80mmHg Daytime BP: Daytime mean SBP<135mmHg and Daytime mean DBP<85mmHg Night time BP: Night time mean SBP<120mmHg and Night time mean DBP<70mmHg <Clinic BP> : Mean sitting systolic blood pressure<140mmHg and Mean sitting diastolic blood pressure<90mmHg
Time Frame
Baseline and week 8
Title
Morning BP Surge
Description
The morning BP surge was calculated as the morning BP minus the lowest BP. Morning BP was defined as the average BP during the first 2 h after waking. The lowest BP was defined as the average of three BP readings focused on the lowest night-time reading (that is, the lowest reading plus the readings immediately before and after)
Time Frame
Baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than 20 years in hypertension patient Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg. Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization Clinic Mean sitting diastolic blood pressure ≥ 90mmHg Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization As night workers who sleep during the day and whose working hours including 00:00 to 04:00 Secondary Hypertension Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c > 8.0%) Severe or malignant retinopathy Abnormal laboratory test results Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 2 Serum creatinine > Upper normal limit X 2 Acute of chronic inflammatory status requiring treatment Need for other antihypertensive drugs during the trial Need for prohibited medication specified in the protocol A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers Severe hypersensitivity to amlodipine or telmisartan History of drug or alcohol abuse within 6 months Surgical or medical conditions History of major gastrointestinal surgery History of active inflammatory bowel syndrome within 12 months Abnormal pancreatic functions Gastrointestinal/rectal bleeding Urinary tract obstruction Administration of other Investigational Product within 30 days Pregnant, breast-feeding and childbearing age who don't use adequate contraception History of malignant tumor within 5 years (including leukemia and lymphoma) Another clinical condition in investigator's judgement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Gu Shin
Phone
82-53-620-3843
Email
dgshin@med.yu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Gu Shin
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korean University Guro Hospital
City
Seoul
State/Province
Guro-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Won Kim
Phone
82-2-2626-3021
Email
kjwmm@korea.ac.kr
Facility Name
Myongji Hospital
City
Goyang
State/Province
Gyeonggi-di
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Young Choi
Phone
82-31-810-6773
Email
tchoicardio@gmail.com
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Wook Kwon
Phone
82-31-910-7041
Email
mdksu@yahoo.co.kr
Facility Name
Bundang Jesaeng Hospital
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Wook Cho
Phone
82-31-779-0379
Email
cswim@dmc.or.kr
Facility Name
Daegu Catholic University Medical Center
City
Dae-gu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Su Lee
Phone
82-53-650-4797
Email
mdleeys@cu.ac.kr
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeong-Seop Park
Phone
82-53-250-7473
Email
drparkgyver@gmail.com
Facility Name
Yeungnam University Medical Center
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Gu Shin
Phone
82-53-620-3843
Email
dgshin@med.yu.ac.kr
Facility Name
Cheju Halla General Hospital
City
Jeju
State/Province
Jeju Special Self-Governing
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Ho Kang
Phone
82-64-740-5002
Email
metronics@paran.com
Facility Name
Dong-A University Hospital
City
Busan
State/Province
Seo-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Sung Park
Phone
82-51-240-2764
Email
thinkmed@dau.ac.kr
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Seo-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang-Su Cha
Phone
82-51-240-7221
Email
chakws1@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled

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