Clinical trial NCT01426100: CKD-828 Telmisartan Non-Responder Trial
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(CKD-828) Versus Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: CKD-828
Hypertension
Primary Hypertension
S-Amlodipine
Telmisartan
Amlodipine
Non-Responder
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* diagnosis of essential hypertension and blood pressure not adequately controlled(inadequate control defined as seated diastolic blood pressure(DBP)\>= 90mmHg if on existing antihypertensive treatment of seated DBP \>= 100mmHg if treatment naive)
* failure to respond to four weeks treatment with telmisartan 40mg(failure to respond defined as seated DBP \>= 90mmHg)
* willing and able to provide written informed consent

Exclusion Criteria:

* mean seated DBP \>= 120mmHg and/or mean seated SBP \>= 200mmHg during run-in treatment or mean seated DBP \>= 120mmHg and/or mean seated SBP \>= 180mmHg at the randomization visit
* known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
* has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
* Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%
* nown severe or malignant retinopathy
* hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT \> UNL X 2, serum creatinine \> UNL X 1.5
* acute or chronic inflammatory status need to treatment
* need to additional antihypertensive drugs during the study
* need to concomitant medications known to affect blood pressure during the study
* history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
* known hypersensitivity related to either study drug
* history of drug or alcohol dependency within 6 months
* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding
* administration of other study drugs within 30 days prior to randomization
* premenopausal women(last menstruation \< 1year) not using adequate contraception, pregnant or breast-feeding
* history of malignancy including leukemia and lymphoma within the past 5 years
* in investigator's judgment

Primary outcomes:
measure: Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: After 4 weeks of treatment
measure: Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: After 4 weeks and 8 weeks of treatment
measure: Response rate
timeFrame: After 4 weeks and 8 weeks of treatment
measure: Control rate
timeFrame: After 4 weeks and 8 weeks of treatment
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Kandong Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Goyang
country: Korea, Republic of
facility: DonGuk University Ilsan Hospital
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Inchon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Bundang Cha Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital, The catholic University of Korea
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: