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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526875
• Other study ID #: 330HT14009
• Status: Recruiting
• Phase: Phase 4
• First received: August 17, 2015
• Last updated: August 18, 2017
• Start date: April 2015
• Est. completion date: November 2017

Study information

• Verified date: August 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: Dong-Gu Shin
• Phone: 82-53-620-3843
• Email: dgshin[@]med.yu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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-? 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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telminuvo®Tab. 40/2.5mg
per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and week 8
Secondary	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	Baseline and week 8
Secondary	Change from baseline in the clinic mean blood pressure at week 8.		Baseline and week 8
Secondary	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; : Mean sitting systolic blood pressure<140mmHg and Mean sitting diastolic blood pressure<90mmHg	Baseline and week 8
Secondary	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)	Baseline and week 8