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Status unknownNCT02526875Updated Aug 22, 2017

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

A Phase 4 interventional study of Telminuvo®Tab. 40/2.5mg in Hypertension, sponsored by Chong Kun Dang Pharmaceutical. Status unknown at 10 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
208
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension, Telmisartan/S-Amlodipine
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 208 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
208 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugTelminuvo®Tab. 40/2.5mg

    per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

    Also known as: Telmisartan/S-Amlodipine 40/2.5mg

06

What researchers measure

Primary outcomes

  1. Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.

    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 outcomes

  1. Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8

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

    Time frame: Baseline and week 8

  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.

    \<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

    Time frame: Baseline and week 8

  4. Morning BP Surge

    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)

    Time frame: Baseline and week 8

07

Study locations

10 of 10 sites recruiting
  • Korean University Guro Hospital
    Seoul, Guro-gu, Korea, Republic of
    Recruiting
  • Myongji Hospital
    Goyang, Gyeonggi-di, Korea, Republic of
    Recruiting
  • Inje University Ilsan Paik Hospital
    Goyang, Gyeonggi-do, Korea, Republic of
    Recruiting
  • Bundang Jesaeng Hospital
    Seongnam, Gyeonggi-do, Korea, Republic of
    Recruiting
  • Daegu Catholic University Medical Center
    Dae-gu, Gyeongsangbuk-do, Korea, Republic of
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, Gyeongsangbuk-do, Korea, Republic of
    Recruiting
  • Yeungnam University Medical Center
    Daegu, Gyeongsangbuk-do, Korea, Republic of
    Recruiting
  • Cheju Halla General Hospital
    Jeju, Jeju Special Self-Governing, Korea, Republic of
    Recruiting
  • Dong-A University Hospital
    Busan, Seo-gu, Korea, Republic of
    Recruiting
  • Pusan National University Hospital
    Busan, Seo-gu, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02526875
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Aug 18, 2015
Start date
Apr 2015
Primary completion
Nov 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
Aug 22, 2017

Study contacts

Dong-Gu Shin
Contact
dgshin@med.yu.ac.kr
82-53-620-3843
Dong-Gu Shin
principal investigator · Yeungnam University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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