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

Phase 4

• Conditions: Hypertension
• Interventions: Drug: Telminuvo®Tab. 40/2.5mg

• Registration Number: NCT02526875
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
night	Telminuvo®Tab. 40/2.5mg	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
morning	Telminuvo®Tab. 40/2.5mg	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

Primary Outcome Measures

Name	Time	Method
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.	Baseline and week 8	Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8	Baseline and week 8	* Daytime: 06:00\~21:59; * Nighttime: 22:00\~05:59; * Morning: 06:00\~11:59
Change from baseline in the clinic mean blood pressure at week 8.	Baseline and week 8
24hr ABPM and Clinic BP control at week 8.	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
Morning BP Surge	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)

Trial Locations

Locations (10)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang, Gyeonggi-di, Korea, Republic of

Korean University Guro Hospital; 🇰🇷 Seoul, Guro-gu, Korea, Republic of

Cheju Halla General Hospital; 🇰🇷 Jeju, Jeju Special Self-Governing, Korea, Republic of

Bundang Jesaeng Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Dae-gu, Gyeongsangbuk-do, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of