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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Carvedilol; Metoprolol

Criteria

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