CKD-828 Telmisartan Non-Responder Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01426100
First received: August 30, 2011
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: CKD-828 40/2.5mg
Drug: CKD-828 40/5mg
Drug: Telmisartan 80mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: No ]
    Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg

  • Control rate [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: No ]
    Reduction SBP < 140mmHg, DBP < 90mmHg


Enrollment: 183
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-828 40/2.5mg Drug: CKD-828 40/2.5mg
Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg
Experimental: CKD-828 40/5mg Drug: CKD-828 40/5mg
Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg
Active Comparator: Telmisartan 80mg Drug: Telmisartan 80mg
Telmisartan 80mg monotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426100

Locations
Korea, Republic of
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
Kyung Hee University Medical Center
Seoul, Korea, Republic of
Bundang Cha Medical Center
Seoul, Korea, Republic of
St. Paul's Hospital, The catholic University of Korea
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Ewha Womans University Hospital
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01426100     History of Changes
Other Study ID Numbers: 130HT11B
Study First Received: August 30, 2011
Last Updated: September 11, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-828
Hypertension
Primary Hypertension
S-Amlodipine
Telmisartan
Amlodipine
Non-Responder

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 28, 2014