Clinical trial NCT02526875: Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension, Telmisartan/S-Amlodipine
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 208
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8
timeFrame: Baseline and week 8
measure: Change from baseline in the clinic mean blood pressure at week 8.
timeFrame: Baseline and week 8
measure: 24hr ABPM and Clinic BP control at week 8.
timeFrame: Baseline and week 8
measure: Morning BP Surge
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korean University Guro Hospital
state: Guro-gu
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-di
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Bundang Jesaeng Hospital
state: Gyeonggi-do
city: Dae-gu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
state: Gyeongsangbuk-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Gyeongsangbuk-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Gyeongsangbuk-do
city: Jeju
country: Korea, Republic of
facility: Cheju Halla General Hospital
state: Jeju Special Self-Governing
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Seo-gu
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
affiliation: Yeungnam University Hospital
name: Dong-Gu Shin
role: PRINCIPAL_INVESTIGATOR
References: