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Vascular Dysfunction in Human Obesity Hypertension

NCT01983462 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-04-14

Study results available
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Summary

The purpose of the study is to test the effects of blocking sympathetic nerve activity with a drug called clonidine on blood vessel function and muscle nerve activity in adults who are obese and have high blood pressure.

The cohort of subjects will consist of 69 healthy young men and women age 18-79 years who are obese, defined as a body mass index \> or = to 30 kg/m2, who have untreated systolic hypertension (systolic blood pressure \> or = to 130 - \<180 mmHg- average of at least 3 measurements 2 min apart after 10 min seated resting position). These 69 subjects will then be randomized to 3 treatment arms: clonidine (0.1 mg/day), hydrochlorothiazide (25 mg/day) or placebo for 4 weeks in years 1 and 2. All tablets will be encapsulated by to look identical. Subjects will randomly (1:1:1) receive one of the following combinations in a double-blind, placebo-controlled design:

1. Oral clonidine (0.1 mg twice/day)
2. Oral hydrochlorothiazide (12.5 mg twice/day)
3. Oral placebo

I

Conditions

Interventions

DRUG

Clonidine

DRUG

Hydrochlorothiazide

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Gary L Pierce, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01983462 on ClinicalTrials.gov