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

August 18, 2017 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

208

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
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of
        • Recruiting
        • Korean University Guro Hospital
        • Contact:
    • Gyeonggi-di
      • Goyang, Gyeonggi-di, Korea, Republic of
        • Recruiting
        • Myongji Hospital
        • Contact:
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Bundang Jesaeng Hospital
        • Contact:
    • Gyeongsangbuk-do
      • Dae-gu, Gyeongsangbuk-do, Korea, Republic of
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
      • Daegu, Gyeongsangbuk-do, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
      • Daegu, Gyeongsangbuk-do, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
    • Jeju Special Self-Governing
      • Jeju, Jeju Special Self-Governing, Korea, Republic of
        • Recruiting
        • Cheju Halla General Hospital
        • Contact:
    • Seo-gu
      • Busan, Seo-gu, Korea, Republic of
        • Recruiting
        • Dong-A University Hospital
        • Contact:
      • Busan, Seo-gu, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Contact:

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: 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
Drug: Telminuvo®Tab. 40/2.5mg
per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Other Names:
  • Telmisartan/S-Amlodipine 40/2.5mg
Active Comparator: 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
Drug: Telminuvo®Tab. 40/2.5mg
per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Other Names:
  • Telmisartan/S-Amlodipine 40/2.5mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the clinic mean blood pressure at week 8.
Time Frame: Baseline and week 8
Baseline and week 8
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8
Time Frame: Baseline and week 8
  • Daytime: 06:00~21:59
  • Nighttime: 22:00~05:59
  • Morning: 06:00~11:59
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<140mmHg and Mean sitting diastolic blood pressure<90mmHg
Baseline and week 8
Morning BP Surge
Time Frame: Baseline and week 8
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)
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: Dong-Gu Shin, Yeungnam University Hospital

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

April 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 330HT14009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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