Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

August 23, 2020 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

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

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 19 or above

  • Inadequately controlled Essential hypertension at Screening

    1. Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1

      • Mean sitDBP ≥ 95mmHg on target arm

    2. Taking antihypertensive drug but not controlled

      • Mean sitDBP ≥ 90mmHg on target arm

  • Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy

    • Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
  • Ability to provide written informed consent

Exclusion Criteria:

  • The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
  • Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
  • Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • Patient with congestive heart failure(NYHA class III, IV)
  • Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
  • History of stroke, cerebral hemorrhage within 6 months
  • Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c > 8.5%
  • History of severe or malignant retinopathy
  • AST/ALT > UNL*3, Serum creatinine > UNL*1.5, K > 5.5mEq/L
  • Patient with acute or chronic inflammatory(treatment required) status
  • Patient who need to take antihypertensive drug besides Investigational products
  • Patient must be treated with medications prohibited for concomitant use during the study period
  • History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
  • Hypersensitive to Candesartan/Amlodipine
  • Patient who are dependent on drugs or alcohol within 6 months
  • History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
  • Patients treated with other investigational product within 30 days at first time taking the investigational product
  • Women with pregnant, breast-feeding
  • History of malignant tumor within 5 years
  • Not eligible to participate for the 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

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 to week 4
From baseline to week 4
The mean change of sitSBP
Time Frame: From baseline to week 4 and 8
From baseline to week 4 and 8
Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg
Time Frame: From baseline to week 8
From baseline to week 8
Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg
Time Frame: From baseline to week 8
From baseline to week 8

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

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 (Actual)

April 22, 2015

Primary Completion (Actual)

February 25, 2016

Study Completion (Actual)

February 29, 2016

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144HT14020

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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