Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension

NCT01413048 | Unknown Phase 3 DMC

• 1 other identifier: 1001AGCVSP3
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.

Conditions

Essential Hypertension

Keywords

Essential Hypertension; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in diastolic blood pressure (DBP)

  8 weeks

Secondary Outcomes (4)

• Change from baseline in diastolic blood pressure (DBP)

  2 weeks

• Change from baseline in systolic blood pressure (SBP)

  2, 8 weeks

• Proportion of patients who reach overall blood pressure control (defined as BP <140/90)

  8 weeks

• Incidence of adverse effects

  8 weeks

Study Arms (2)

AGSCT101

EXPERIMENTAL

Drug: AGSCT101 12.5mg

Carvedilol

ACTIVE COMPARATOR

Drug: Carvedilol 25mg

Interventions

Carvedilol 25mg DRUG

Tablet, q.d.

Carvedilol

AGSCT101 12.5mg DRUG

Tablet, q.d.

AGSCT101

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients ≥ 19 years of age
• Mild to moderate essential hypertension: sDBP 90 \~ 109, sSBP 140 \~ 179
• Subjects who agree to participate in this sudy and give written informed consent
• Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

You may not qualify if:

• The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg
• Patients with postural hypotension
• Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease
• Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
• Patients judged to have a history of alcohol or drug abuse by the investigator
• Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
• Patients with uncontrolled diabetes mellitus
• Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Carvedilol

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

• Ki-Bae Seung, Professor

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

  PRINCIPAL INVESTIGATOR

• Hun-Sik Park, Professor

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

• Chang-Gyu Park, Professor

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Moo-Yong Rhee, Professor

  Dongguk University Medical Center

  PRINCIPAL INVESTIGATOR

• Dong-Ju Choi, Professor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Seung-Jea Tahk, Professor

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jung-Han Yoon, Professor

  Wonju Christian Hospital

  PRINCIPAL INVESTIGATOR

• Sung-Ha Park, Professor

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Myung-Ho Jeong, Professor

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Sang-Wook Kim, Professor

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Young Yoon, Manager

CONTACT

+82-2-3289-4257; syyoon@ahn-gook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2011
• First Posted: August 10, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 10, 2011

Record last verified: 2011-08

Locations

KR (1)