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

NCT02526875 | Unknown Phase 4

• 1 other identifier: 330HT14009
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 10

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

Conditions

Hypertension

Keywords

hypertension, Telmisartan/S-Amlodipine

Outcome Measures

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.

  Baseline and week 8

Secondary Outcomes (4)

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

  Baseline and week 8

• 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

• Morning BP Surge

  Baseline and week 8

Study Arms (2)

night

EXPERIMENTAL

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

morning

ACTIVE COMPARATOR

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

Telminuvo®Tab. 40/2.5mg DRUG

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

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

morning; night

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 20 years in hypertension patient
• 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.
• Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
• Clinic Mean sitting diastolic blood pressure ≥ 90mmHg
• Patient who decided to participate and signed on an informed consent form willingly

You may not qualify if:

• Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization
• As night workers who sleep during the day and whose working hours including 00:00 to 04:00
• Secondary Hypertension
• 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
• Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
• type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c \> 8.0%)
• Severe or malignant retinopathy
• Abnormal laboratory test results
• Aspartate aminotransferase/Alanine aminotransferase \> Upper normal limit X 2
• Serum creatinine \> Upper normal limit X 2
• Acute of chronic inflammatory status requiring treatment
• Need for other antihypertensive drugs during the trial
• Need for prohibited medication specified in the protocol
• A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
• Severe hypersensitivity to amlodipine or telmisartan

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (10)

Korean University Guro Hospital

Seoul, Guro-gu, South Korea

RECRUITING

Myongji Hospital

Goyang, Gyeonggi-di, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Bundang Jesaeng Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Daegu Catholic University Medical Center

Dae-gu, Gyeongsangbuk-do, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangbuk-do, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, Gyeongsangbuk-do, South Korea

RECRUITING

Cheju Halla General Hospital

Jeju City, Jeju Special Self-Governing, South Korea

RECRUITING

Dong-A University Hospital

Busan, Seo-gu, South Korea

RECRUITING

Pusan National University Hospital

Busan, Seo-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong-Gu Shin

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Gu Shin

CONTACT

82-53-620-3843; dgshin@med.yu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 18, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)