Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

NCT00553969 | Completed Phase 1 Results

• 1 other identifier: 0709M15829
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.

Conditions

Pre-hypertension

Keywords

cardiovascular disease prevention

Outcome Measures

Primary Outcomes (1)

• Change in Disease Score (DS) Among the Treatment Groups

  Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.

  Baseline and nine months

Study Arms (4)

1

EXPERIMENTAL

Coreg CR + lisinopril

Drug: carvedilol phosphate and lisinopril

2

EXPERIMENTAL

Coreg CR + placebo

Drug: carvedilol phosphate

3

EXPERIMENTAL

lisinopril + placebo

Drug: lisinopril

4

PLACEBO COMPARATOR

placebo + placebo

Drug: placebo and placebo

Interventions

carvedilol phosphate DRUG

Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months

Also known as: Coreg CR

2

lisinopril DRUG

tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

3

carvedilol phosphate and lisinopril DRUG

carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

Also known as: Coreg CR (carvedilol phosphate)

1

placebo and placebo DRUG

capsule once daily for 9 months; dosage unknown

4

Eligibility Criteria

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

You may qualify if:

• Males and females \> 18 years old with pre-hypertensive or borderline blood pressures (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg) deemed not to need antihypertensive therapy. Subjects must also have one additional risk factor for cardiovascular disease, including:
• LDL \> 130 and \< 160 mg/dL
• HDL \< 40 mg/dL
• Fasting blood sugar \>100 and \< 126 mg/dL
• Body mass index ≥ 30
• Smoker
• Family history of premature heart disease or hypertension

Sponsors & Collaborators

• University of Minnesota: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Minnesota, Variety Club Research Center 102

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Prehypertension

Interventions

Carvedilol; Lisinopril

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; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jay N. Cohn, M.D.
• Organization: University of Minnesota Medical School

cohnx001@umn.edu

612.625.5646

Study Officials

• Jay N Cohn, MD

  Professor, University of Minnesota, Cardiology Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 24, 2018
• Results First Posted: December 17, 2014

Record last verified: 2018-03

Locations

US (1)