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

Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01970059
Enrollment
302
Registered
2013-10-25
Start date
2013-10-31
Completion date
Unknown
Last updated
2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension

Brief 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

Interventions

Sponsors

Jiangsu HengRui Medicine Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8Baseline and Week 8

Secondary

MeasureTime frame
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8Baseline and Week 8
Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8Week 8

Countries

China

Contacts

Primary ContactYun Zhang, Professor
yun-zhang@163.com86 135731022060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026