Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
NCT ID: NCT02526875
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
208 participants
INTERVENTIONAL
2015-04-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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night
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
per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg
morning
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
Telminuvo®Tab. 40/2.5mg
per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg
Interventions
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Telminuvo®Tab. 40/2.5mg
per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Dong-Gu Shin
Role: PRINCIPAL_INVESTIGATOR
Yeungnam University Hospital
Locations
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Korean University Guro Hospital
Seoul, Guro-gu, South Korea
Myongji Hospital
Goyang, Gyeonggi-di, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Bundang Jesaeng Hospital
Seongnam-si, Gyeonggi-do, South Korea
Daegu Catholic University Medical Center
Dae-gu, Gyeongsangbuk-do, South Korea
Keimyung University Dongsan Medical Center
Daegu, Gyeongsangbuk-do, South Korea
Yeungnam University Medical Center
Daegu, Gyeongsangbuk-do, South Korea
Cheju Halla General Hospital
Jeju City, Jeju Special Self-Governing, South Korea
Dong-A University Hospital
Busan, Seo-gu, South Korea
Pusan National University Hospital
Busan, Seo-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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330HT14009
Identifier Type: -
Identifier Source: org_study_id
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