The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients

NCT00459056 | Completed Phase 3 Results

• 1 other identifier: SPHC 2007-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.

Conditions

Abdominal Obesity; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)

  Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.

  Change from three months to seven months

Study Arms (2)

Carvediolol CR + Lisinopril, then Lisinopril + HCTZ

EXPERIMENTAL

Subjects were randomly assigned to Carvedilol CR + Lisinopril for three months, then had a washout period of one month, and then were given Lisinopril + HCTZ for the final three months.

Drug: Carvedilol CR + Lisinopril; Drug: Lisinopril + HCTZ

Lisinopril + HCTZ, then Carvedilol CR + Lisinopril

ACTIVE COMPARATOR

Subjects were randomally assigned to Lisinopril + HCTZ for three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.

Drug: Carvedilol CR + Lisinopril; Drug: Lisinopril + HCTZ

Interventions

Carvedilol CR + Lisinopril DRUG

Participants were given Carvedilol CR + Lisinopril for three months. Oral medication. Carvedilol CR and Lisinopril combination therapy was initiated at 20 mg and 10 mg, respectively. Patients returned one week later and doses of carvedilol CR and lisinopril were increased to 40 mg and 20 mg, respectively, depending on blood pressure.

Also known as: Prinivil, Coreg

Carvediolol CR + Lisinopril, then Lisinopril + HCTZ; Lisinopril + HCTZ, then Carvedilol CR + Lisinopril

Lisinopril + HCTZ DRUG

Participants were given Lisinopril + HCTZ for three months. Oral medication. Lisinopril + HCTZ combination therapy was initiated at 12.5 mg and 10 mg, respectively. Patients returned 1 week later and doses of hydrochlorothiazide and lisinopril were increased to 25 mg and 20 mg, respectively, depending on blood pressure levels.

Also known as: Prinivil, Hydrochlorothiazide

Carvediolol CR + Lisinopril, then Lisinopril + HCTZ; Lisinopril + HCTZ, then Carvedilol CR + Lisinopril

Eligibility Criteria

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

You may qualify if:

• \>18 years old
• Systolic blood pressure (SBP) \>130 and/or diastolic blood pressure (DBP) \>85 (or currently taking anti-hypertensive medication)
• Waist circumference \>102 cm (men) and \>88 cm (women)
• Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

You may not qualify if:

• Use of anti-hypertensive medications within one month of randomization (patients may be washed-out from anti-hypertensive medications)
• Unstable angina
• History of angina symptoms within 3 months of screening
• Decompensated heart failure
• History of myocardial infarction
• Stroke or coronary artery bypass graft within 3 months of screening
• Standard clinical contraindications to beta-blocker therapy
• Standard clinical contraindications to ACE-I therapy
• Women who are currently pregnant or planning to become pregnant (pregnancy testing will occur at specific intervals throughout study and women will be informed of potential risks during the consenting process; information specific to this risk will be detailed in the consent form)
• Breastfeeding women
• Clinically significant liver disease
• Creatinine \> 2.5 mg/dL
• Hepatic function greater than 3 times upper limit of normal

Sponsors & Collaborators

• St. Paul Heart Clinic: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal; Hypertension

Interventions

Carvedilol; Lisinopril; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Limitations and Caveats

crossover study design

Results Point of Contact

• Title: Aaron S. Kelly, Ph.D.
• Organization: University of Minnesota

kelly105@umn.edu

612-626-3492

Study Officials

• Aaron S Kelly, PhD

  St. Paul Heart Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 6, 2013
• Results First Posted: November 8, 2013

Record last verified: 2013-11

Locations

US (1)