CKD-828 Telmisartan Non-Responder Trial
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: CKD-828 40/2.5mg (Drug); CKD-828 40/5mg (Drug); Telmisartan 80mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Chong Kun Dang Pharmaceutical
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Sitting Diastolic Blood Pressure (MSDBP)
Secondary outcome: Mean Sitting Diastolic Blood Pressure (MSDBP)Mean Sitting Systolic Blood Pressure (MSSBP) Response rate Control rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kandong Sacred Heart Hospital, Anyang, Korea, Republic of
Daegu Catholic University Medical Center, Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of
DonGuk University Ilsan Hospital, Goyang, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital, Goyang, Korea, Republic of
Gachon University Gil Medical Center, Inchon, Korea, Republic of
Chonbuk National University Hospital, Jeonju, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of
Bundang Cha Medical Center, Seoul, Korea, Republic of
Ewha Womans University Hospital, Seoul, Korea, Republic of
Gangnam Severance Hospital, Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital, Seoul, Korea, Republic of
Korea University Guro Hospital, Seoul, Korea, Republic of
Kyung Hee University Medical Center, Seoul, Korea, Republic of
Severance Hospital, Seoul, Korea, Republic of
Soon Chun Hyang University Hospital, Seoul, Korea, Republic of
St. Paul's Hospital, The catholic University of Korea, Seoul, Korea, Republic of
Ajou University Hospital, Suwon, Korea, Republic of
Additional Information
Starting date: August 2011
Last updated: September 11, 2012
|