CKD-828 Primary Hypertension Trial(Dose-selection)

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01128322
First received: May 20, 2010
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).


Condition Intervention Phase
Hypertension
Drug: S-Amlodipine, Telmisartan
Drug: S-Amlodipine
Drug: Telmisartan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Multi-factorial, Phase 2 Trial to Evaluate the Efficacy and Safety of S-Amlodipine/Telmisartan Combined or Alone and Select Better Dose of CKD-828 in Patients With Essential Hypertension

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: Yes ]

Secondary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure(MSDBP) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Mean Sitting Systolic Blood Pressure(MSSBP) [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
    Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg

  • Control rate [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
    Reduction SBP < 140mmHg, DBP < 90mmHg


Estimated Enrollment: 430
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-Amlodipine 2.5mg + Telmisartan 40mg Drug: S-Amlodipine, Telmisartan
Experimental: S-Amlodipine 2.5mg + Telmisartan 80mg Drug: S-Amlodipine, Telmisartan
Experimental: S-Amlodipine 5mg + Telmisartan 40mg Drug: S-Amlodipine, Telmisartan
Experimental: S-Amlodipine 5mg + Telmisartan 80mg Drug: S-Amlodipine, Telmisartan
Active Comparator: S-Amlodipine 2.5mg Drug: S-Amlodipine
Active Comparator: S-Amlodipine 5mg Drug: S-Amlodipine
Active Comparator: Telmisartan 40mg Drug: Telmisartan
Active Comparator: Telmisartan 80mg Drug: Telmisartan
Placebo Comparator: Placebo Drug: Placebo

  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
  • stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg
  • ability to provide written informed consent

Exclusion Criteria:

  • severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg
  • 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 Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
  • known 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
  • 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, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
  • cannot swallow investigational products
  • administration of other study drugs within 4 weeks prior to randomization
  • premenopausal women(last menstration < 1year) not using adequte 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: NCT01128322

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Soonchunhyang University Hospital in Bucheon
Bucheon, Korea, Republic of
Kosin University Gospel Hospital
Busan, Korea, Republic of
Chungbuk National Uiversity Hospital
Cheongju, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Goyang, Korea, Republic of
DonGuk University International Hospital
Goyang, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Gachon University Gil Medical Center
Inchon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyung Hee University Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
St. Paul's Hospital, The catholic University of Korea
Seoul, Korea, Republic of
Ewha Womans University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The catholic University of Korea
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
Seoul, Korea, Republic of
Kandong Sacred Heart Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Uijeongbu St. Mary's Hospital, The catholic University of Korea
Uijeongbu, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
  More Information

No publications provided

Responsible Party: Jin Kim / Director
ClinicalTrials.gov Identifier: NCT01128322     History of Changes
Other Study ID Numbers: 128HT09K
Study First Received: May 20, 2010
Last Updated: April 22, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-828
Hypertension
Primary Hypertension
S-Amlodipine
Telmisartan
Amlodipine
Factorial
Phase 2

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 21, 2014