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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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