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

January 29, 2020 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Ansan-si
      • Gyeonggi-do, Ansan-si, Korea, Republic of
        • Korea University Ansan Hospital
    • Aran
      • Jeju, Aran, Korea, Republic of
        • Jeju National University Hospital
    • Bundang-gu
      • Seongnam, Bundang-gu, Korea, Republic of
        • Bundang Cha Hospital
      • Seongnam, Bundang-gu, Korea, Republic of
        • Seoul university Bundang hospital
    • Dongdaemun-gu
      • Seoul, Dongdaemun-gu, Korea, Republic of
        • Kyunghee University Medical Center
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of
        • Gangnam Severance Hospital
    • Gyeongsangbuk-do
      • Gumi, Gyeongsangbuk-do, Korea, Republic of
        • Kumi Cha Hospital
    • Jongro-gu
      • Seoul, Jongro-gu, Korea, Republic of
        • Seoul university hospital
    • Jung-gu
      • Seoul, Jung-gu, Korea, Republic of
        • National Medical Center
    • Seo-gu
      • Busan, Seo-gu, Korea, Republic of
        • Kosin University Gospel Hospital
    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of
        • Hallym University Kangnam Sacred Heart Hosipital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Telmisartan 80mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Time Frame: Baseline and week 8
Baseline and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and week 8
Change from baseline in the clinic mean blood pressure at week 8.
Time Frame: Baseline and week 8
Baseline and week 8
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)
Baseline and week 8
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
Baseline and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Hyo-Soo Kim, Professor, Seoul university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 330HT13010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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