A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Hypertension

Treatments: Drug: Extended-Release Carvedilol Sulfate; Drug: Sustained-release Metoprolol Succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970059

KWDLEH2012

Details and patient eligibility

About

The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension

Enrollment: 302 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or Females
• Aged from 18 to 70 years
• Had a history of essential hypertension
• Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg

Exclusion criteria

• Malignant hypertension
• Average sitting systolic blood pressure≧180mmHg
• Type 2 diabetes with hemoglobin A1c≥9%
• Type 1 diabetes
• New York Heart Association class Ⅱ-Ⅳ congestive heart-failure
• Unstable angina
• Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
• Atrial fibrillation
• Bradycardia (<60 bpm, seated)
• Asthma or other obstructive pulmonary disease
• History of myocardial infarction
• Stroke in the 6 months before screening
• Known contraindications to β-adrenergic blocker therapy
• Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>3 times upper limit of normal
• Crea>2 times upper limit of normal
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 2 patient groups

Extended-Release Carvedilol Sulfate

Experimental group

Description:

18-72mg/d,po

Treatment:

Drug: Extended-Release Carvedilol Sulfate

Sustained-release Metoprolol Succinate

Active Comparator group

Description:

47.5-190mg/d,po

Treatment:

Drug: Sustained-release Metoprolol Succinate