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Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.

NCT00430040 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-04-16

Study results available
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Summary

To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by suppressing free radicals(charged substances that cause damage to the body ) and inflammation.

Conditions

Interventions

DRUG

Carvedilol Controlled Release (CR)

lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study. Initial dose: Carvedilol CR (20 mg QD, dose level 1) Titration: If tolerated, increase the dosage to 20 mg QD, 40 mg QD, and 80mg QD orally over successive intervals of at least 2 weeks to achieve target blood pressure sSBP \<130 and sDBP \< 80

DRUG

lisinopril

lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study

Sponsors & Collaborators

Principal Investigators

  • Paresh Dandona, MD, PhD · Kaleida Health / University at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00430040 on ClinicalTrials.gov