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Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Carvedilol SR 32mg, QD

Carvedilol SR 64mg, QD

Carvedilol IR 25mg, QD

Carvedilol IR 25mg, BID

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Carvedilol SR, Carvedilol IR, Hypertension, Essential Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18 years or older
at the screening visit(visit 1)
- antihypertensive drugs not taking: 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
- antihypertensive drugs taking: mean sitDBP ≤ 104mmHg and mean sitSBP < 180mmHg
at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
willing and able to provide written informed consent

Exclusion Criteria:

At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg)
known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c > 9%)
Corresponding to the following
- has severe heart disease(Heart failure NYHA functional class 3, 4)
- ischaemic heart diseases within 6 months (unstable angina or myocardial infarction)
- myocardiopathy
- Cor pulmonale
- aortic stenosis , aortic valvular stenosis , mitral stenosis
- abnormality of the conduction system as 2nd degree AV block, Complete AV block, Sick Sinus Syndrome, Sinus Block(In particular, pulse <50beats / min)
- has heart attack with complication.
has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease.
Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
Fluid retention or overload to required intravenous inotropes.
known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
defined by the following laboratory parameters:
- hepatic dysfunction(AST/ALT ≥ UNL X 3)
- renal dysfunction(serum creatinine ≥ UNL X 2)
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)
history of drug or alcohol dependency within 6 months
premenopausal women(last menstruation < 12 months) not using adequate contraception, pregnant or breast-feeding
chronic inflammatory status need to treatment
known hypersensitivity related to carvedilol
history of malignancy including leukemia and lymphoma within the past 5 years
administration of other study drugs within 28 days prior to the first IP administration
in investigator's judgment

Sites / Locations

The Hanyang Universitiy Guri Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carvedilol SR 32mg, 64mg

Carvedilol IR 25mg

Arm Description

•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.

•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.

Outcomes

Primary Outcome Measures

Mean Sitting Diastolic Blood Pressure (MSDBP)

Secondary Outcome Measures

Mean Sitting systolic Blood Pressure (MSSBP)

Control Rate

Sitting DBP<90mmHg, Sitting SBP<140mmHg

Response Rate

Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg

Full Information

NCT ID

NCT01756430

First Posted

December 20, 2012

Last Updated

January 13, 2014

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01756430

Brief Title

Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension

Official Title

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension

Detailed Description

In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks. This study is consist of placebo run-in period(2~4 weeks_single blind) and treatment period(8 weeks_double blind).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Carvedilol SR, Carvedilol IR, Hypertension, Essential Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carvedilol SR 32mg, 64mg

Arm Type

Experimental

Arm Description

•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.

Arm Title

Carvedilol IR 25mg

Arm Type

Active Comparator

Arm Description

•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Carvedilol SR 32mg, QD

Other Intervention Name(s)

Dilatrend SR

Intervention Description

Carvedilol SR 32mg QD for 4 weeks With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Carvedilol SR 64mg, QD

Other Intervention Name(s)

Dilatrend SR

Intervention Description

Carvedilol SR 64mg QD for 4 weeks With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Carvedilol IR 25mg, QD

Other Intervention Name(s)

Dilatrend IR

Intervention Description

Carvedilol IR 25mg QD for 4 weeks With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Carvedilol IR 25mg, BID

Other Intervention Name(s)

Dilatrend IR

Intervention Description

Carvedilol IR 25mg BID for 4 weeks With the others investigation product placebo 2 capsules QD for 4 weeks.

Primary Outcome Measure Information:

Title

Mean Sitting Diastolic Blood Pressure (MSDBP)

Time Frame

After 4 and 8 weeks of treatment

Secondary Outcome Measure Information:

Title

Mean Sitting systolic Blood Pressure (MSSBP)

Time Frame

After 4 weeks and 8 weeks of treatment

Title

Control Rate

Description

Sitting DBP<90mmHg, Sitting SBP<140mmHg

Time Frame

After 8 weeks of treatment

Title

Response Rate

Description

Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg

Time Frame

After 8 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18 years or older at the screening visit(visit 1) antihypertensive drugs not taking: 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg antihypertensive drugs taking: mean sitDBP ≤ 104mmHg and mean sitSBP < 180mmHg at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg willing and able to provide written informed consent Exclusion Criteria: At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg) known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c > 9%) Corresponding to the following has severe heart disease(Heart failure NYHA functional class 3, 4) ischaemic heart diseases within 6 months (unstable angina or myocardial infarction) myocardiopathy Cor pulmonale aortic stenosis , aortic valvular stenosis , mitral stenosis abnormality of the conduction system as 2nd degree AV block, Complete AV block, Sick Sinus Syndrome, Sinus Block(In particular, pulse <50beats / min) has heart attack with complication. has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication) Fluid retention or overload to required intravenous inotropes. known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months) defined by the following laboratory parameters: hepatic dysfunction(AST/ALT ≥ UNL X 3) renal dysfunction(serum creatinine ≥ UNL X 2) 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) history of drug or alcohol dependency within 6 months premenopausal women(last menstruation < 12 months) not using adequate contraception, pregnant or breast-feeding chronic inflammatory status need to treatment known hypersensitivity related to carvedilol history of malignancy including leukemia and lymphoma within the past 5 years administration of other study drugs within 28 days prior to the first IP administration in investigator's judgment

Overall Study Officials: