CKD-828 Primary Hypertension Trial(Dose-selection)

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

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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Telmisartan; Drug: S-Amlodipine, Telmisartan; Drug: S-Amlodipine

• Study Type: Interventional
• Enrollment (Anticipated): 430
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Hospital in Bucheon
  • Busan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Cheongju, Korea, Republic of
    • Chungbuk National Uiversity Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Goyang, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Goyang, Korea, Republic of
    • DonGuk University International Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Inchon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Seoul, Korea, Republic of
    • Ewha Womans University 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
    • Kandong Sacred heart Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital, The Catholic University of Korea
  • Wonju, Korea, Republic of
    • Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Active Comparator: Telmisartan 80mg	Drug: Telmisartan
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Sitting Diastolic Blood Pressure(MSDBP)	After 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg	After 4 weeks and 8 weeks of treatment
Control rate	Reduction SBP < 140mmHg, DBP < 90mmHg	After 4 weeks and 8 weeks of treatment
Mean Sitting Diastolic Blood Pressure(MSDBP)		After 4 weeks of treatment
Mean Sitting Systolic Blood Pressure(MSSBP)		After 4 weeks and 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimate): May 21, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2011
• Last Update Submitted That Met QC Criteria: April 22, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension; Telmisartan; Phase 2; Amlodipine; Primary Hypertension; CKD-828; S-Amlodipine; Factorial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Membrane Transport Modulators; Vitamins; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Vitamin B Complex; Amlodipine; Niacin; Telmisartan
• Other Study ID Numbers: 128HT09K