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The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy (TENUVA-BP)

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ClinicalTrials.gov Identifier: NCT02231788
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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Brief Summary:
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telminuvo®Tab. 40/2.5mg Drug: Telmitrend®Tab. 80mg Phase 4

Detailed Description:
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Actual Study Start Date : June 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Telminuvo®Tab. 40/2.5mg
Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg
 Drug: Telminuvo®Tab. 40/2.5mg
Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Other Name: Telmisartan/S-Amlodipine 40/2.5mg
Active Comparator: Telmitrend®Tab. 80mg
Telmitrend®Tab.(Telmisartan) 80mg
 Drug: Telmitrend®Tab. 80mg
Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Other Name: Telmisartan 80mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8. [ Time Frame: Baseline and week 8 ]

    Each timepoint is as following:

    • Daytime: 06:00~21:59
    • Nighttime: 22:00~05:59
    • Morning: 06:00~11:59

  2. Change from baseline in the clinic mean blood pressure at week 8. [ Time Frame: Baseline and week 8 ]
  3. 24hr ABPM and Clinic BP control at week 8. [ Time Frame: Baseline and 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(MSSBP)<140mmHg and Mean sitting diastolic blood pressure(MSDBP)<90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP<130mmHg and MSDBP<80mmHg)


  4. 24hr ABPM and Clinic BP response at week 8. [ Time Frame: Baseline and week 8 ]

    <24hr ABPM> 24hr mean SBP and DBP reduction≥10mmHg

    <Clinic BP> MSSBP and MSDBP≥10mmHg



Eligibility Criteria
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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. More than 19 years in hypertension patient

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

    • Clinic MSSBP ≥ 140mmHg

    • Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease

      • Diabetes mellitus

        • Before screening, diagnosed with diabetes mellitus being treated with oral hypoglycemic agents at least 30 days OR
        • Patients who meet the following results of laboratory tests at the time of randomization. : Fasting plasma glucose ≥ 126mg/dL

      • Chronic kidney disease

        • Patients who meet the following results of laboratory tests at the time of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration rate ≤ 60mL/min/1.73m2
  3. Patient who decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

  1. Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg 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. Abnormal laboratory test results

    • Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3
    • Serum creatinine > Upper normal limit X 4
  4. Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.
  5. 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
  6. Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
  7. Patient who is planning for a renal transplantation during the trial
  8. Severe or malignant retinopathy
  9. Acute of chronic inflammatory status requiring treatment
  10. A history of cancer within five years
  11. A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
  12. Severe hypersensitivity to amlodipine or telmisartan

  13. 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
  14. Need for other antihypertensive drugs during the trial
  15. Need for prohibited medication specified in the protocol
  16. Administration of other Investigational Product within 30 days
  17. History of drug or alcohol abuse within 6 months
  18. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
  19. Another clinical condition in investigator's judgement
Contacts and Locations
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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): NCT02231788


Locations
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Korea, Republic of
Korea University Ansan Hospital
Gyeonggi-do, Ansan-si, Korea, Republic of
Jeju National University Hospital
Jeju, Aran, Korea, Republic of
Bundang Cha Hospital
Seongnam, Bundang-gu, Korea, Republic of
Seoul University Bundang Hospital
Seongnam, Bundang-gu, Korea, Republic of
KyungHee University Medical Center
Seoul, Dongdaemun-gu, Korea, Republic of
Gangnam Severance Hospital
Seoul, Gangnam-gu, Korea, Republic of
Kumi cha Hospital
Gumi, Gyeongsangbuk-do, Korea, Republic of
Seoul University Hospital
Seoul, Jongro-gu, Korea, Republic of
National Medical Center
Seoul, Jung-gu, Korea, Republic of
Kosin University Gospel Hospital
Busan, Seo-gu, Korea, Republic of
Hallym University Kangnam Sacred Heart Hosipital
Seoul, Yeongdeungpo-gu, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Hyo-Soo Kim, Professor Seoul University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02231788    
Other Study ID Numbers: 330HT13010
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: March 2018
Keywords provided by Chong Kun Dang Pharmaceutical:
Telminuvo
Telmitrend
Hypertension
 24hr ABPM
Telmisartan
S-amlodipine
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists