A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension

March 27, 2015 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

456

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Cheol-Ho Kim, M.D., Ph.D.
        • Principal Investigator:
          • Cheol-Ho Kim, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 of 18 or above
  • Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
  • Ability to provide written informed consent

Exclusion Criteria:

  • nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
  • The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
  • Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
  • History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8%
  • History of severe or malignant retinopathy
  • AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L
  • Patients with acute or chronic inflammatory status, autoimmune disease
  • Patients who need to take antihypertensive drug besides Investigational products
  • Patients must be treated with medications prohibited for concomitant use during study period
  • Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
  • Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
  • History of malignant tumor within 5 years
  • Patients who are dependent on drugs or alcohol
  • History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
  • Patients treated with other investigational product within 4 weeks at the time concents are obtained
  • Women with pregnant, breast-feeding
  • Not eligible to participate for study at the discretion of investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Candesartan 16mg + Amlodipine 5mg
Candesartan 16mg + Amlodipine 5mg, po, q.d.
Drug: Amlodipine 5mg
Once a day, 8 weeks
Drug: Candesartan 16mg
Once a day, 8 weeks
Experimental: Candesartan 16mg + Amlodipine 10mg
Candesartan 16mg + Amlodipine 10mg, po, q.d.
Drug: Amlodipine 10mg
Once a day, 8 weeks
Drug: Candesartan 16mg
Once a day, 8 weeks
Active Comparator: Candesartan 16mg
Candesartan 16mg, po, q.d.
Drug: Candesartan 16mg
Once a day, 8 weeks
Experimental: Candesartan 8mg + Amlodipine 5mg
Candesartan 8mg + Amlodipine 5mg, po, q.d.
Drug: Candesartan 8mg
Once a day, 8 weeks
Drug: Amlodipine 5mg
Once a day, 8 weeks
Experimental: Candesartan 8mg + Amlodipine 10mg
Candesartan 8mg + Amlodipine 10mg, po, q.d.
Drug: Candesartan 8mg
Once a day, 8 weeks
Drug: Amlodipine 10mg
Once a day, 8 weeks
Active Comparator: Candesartan 8mg
Candesartan 8mg, po, q.d.
Drug: Candesartan 8mg
Once a day, 8 weeks
Active Comparator: Amlodipine 5mg
Amlodipine 5mg, po, q.d.
Drug: Amlodipine 5mg
Once a day, 8 weeks
Active Comparator: Amlodipine 10mg
Amlodipine 10mg, po, q.d.
Drug: Amlodipine 10mg
Once a day, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean change of sitDBP (sitting diastolic blood pressure)
Time Frame: From baseline at week 8
From baseline at week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean change of sitDBP
Time Frame: From baseline at week 4 and week 8
From baseline at week 4 and week 8
The mean change of sitSBP
Time Frame: From baseline at week 4 and 8
From baseline at week 4 and 8
Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
Time Frame: From baseline at week 4 and 8
From baseline at week 4 and 8
Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
Time Frame: At week 4 and 8
At week 4 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Cheol-Ho Kim, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144HT13021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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