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

NCT01756430 | Completed Phase 3

• 1 other identifier: 125HT12001
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

Carvedilol SR; Carvedilol IR; Hypertension; Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Sitting Diastolic Blood Pressure (MSDBP)

  After 4 and 8 weeks of treatment

Secondary Outcomes (3)

• Mean Sitting systolic Blood Pressure (MSSBP)

  After 4 weeks and 8 weeks of treatment

• Control Rate

  After 8 weeks of treatment

• Response Rate

  After 8 weeks of treatment

Study Arms (2)

Carvedilol SR 32mg, 64mg

EXPERIMENTAL

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

Drug: Carvedilol SR 32mg, QD; Drug: Carvedilol SR 64mg, QD

Carvedilol IR 25mg

ACTIVE COMPARATOR

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

Drug: Carvedilol IR 25mg, QD; Drug: Carvedilol IR 25mg, BID

Interventions

Carvedilol SR 32mg, QD DRUG

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

Also known as: Dilatrend SR

Carvedilol SR 32mg, 64mg

Carvedilol SR 64mg, QD DRUG

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

Also known as: Dilatrend SR

Carvedilol SR 32mg, 64mg

Carvedilol IR 25mg, QD DRUG

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

Also known as: Dilatrend IR

Carvedilol IR 25mg

Carvedilol IR 25mg, BID DRUG

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

Also known as: Dilatrend IR

Carvedilol IR 25mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

The Hanyang Universitiy Guri Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Carvedilol; BID protein, human

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Soon Kill Kim

  The Hanyang Universitiy Guri Hospital

  PRINCIPAL INVESTIGATOR

• Sang-Hyun Ihm

  The Catholic University of Korea Bucheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Sang Hong Haek

  The Catholic University of Korea, Seoul St. Vincent's Hospital

  PRINCIPAL INVESTIGATOR

• Jin-Bae Kim

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Dong Woon Jeon

  National Health Insurance Service Ilsan Hospital

  PRINCIPAL INVESTIGATOR

• Chang-Wook Nam

  Keimyung University, Donsan Hospital

  PRINCIPAL INVESTIGATOR

• Dong-Ju Choi

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Min Su Hyon

  Soon Chun Hyang University Hospital

  PRINCIPAL INVESTIGATOR

• Young Jin Choi

  Sejong General Hospital

  PRINCIPAL INVESTIGATOR

• Hyuck Moon Kwon

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Geu Ru Hong

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Byung-Su Yoo

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

• Ji-Hyun Lim

  Jesus hospital

  PRINCIPAL INVESTIGATOR

• Young Keun Ahn

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Jin Ho Shin

  Hanyang University Seoul Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

KR (1)