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Alpha-2 Adrenergic Agonist

Clonidine + Hydrochlorothiazide for High Blood Pressure (SELECT Trial)

Phase < 1
Recruiting
Led By Gary Pierce, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If subject is on antihypertensive medications, they will stop taking medication for a one-week washout period after Visit 1 before they return for Visit 2. They will come in at day 3 and day 7 of the one-week washout for a BP reading, to confirm that systolic BP is <160 mmHg.
Age 60-85
Must not have
Subjects not on antihypertensive will not be eligible if their resting clinic systolic BP is <130 mmHg or >160 mmHg and diastolic BP >90 mmHg
Women must be postmenopausal for at least 6 months (surgical or natural) and not currently on hormone replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 4 weeks
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved

Summary

This trial will study if nerve activity from the brain contributes to the stiffening of blood vessels in older adults, which can lead to cardiovascular disease.

Who is the study for?
This trial is for non-smoking adults aged 60-85 with untreated or treated stage 1 or 2 isolated systolic hypertension. Participants must be clinically healthy and not on certain medications like aspirin, NSAIDs, vitamins, or supplements. Women should be postmenopausal without hormone therapy. Those with a history of serious health conditions such as heart disease, diabetes, cancer are excluded.
What is being tested?
The study tests if reducing nerve activity from the brain can decrease stiffness in large arteries to prevent cardiovascular diseases. It compares the effects of Clonidine (a blood pressure medication) and Hydrochlorothiazide (a diuretic) against a placebo in older adults with high systolic blood pressure.
What are the potential side effects?
Possible side effects include dizziness, dry mouth, fatigue due to Clonidine; dehydration or electrolyte imbalance from Hydrochlorothiazide; and no active treatment-related side effects from the placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stop my blood pressure medication for a week and have a systolic BP under 160 mmHg.
Select...
I am between 60 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood pressure is not between 130/90 and 160/90 mmHg without medication.
Select...
I am a woman who has been postmenopausal for at least 6 months and am not on hormone replacement therapy.
Select...
I can stop taking aspirin, NSAIDs, vitamins, herbal supplements, and omega-3 for a week before and during the study.
Select...
I am not taking blood thinners, SSRIs, or PDE5 inhibitors.
Select...
I have no history of major heart, lung, liver diseases, diabetes, cancer treatments, mental illness, or use of aspirin/NSAIDs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in carotid-femoral pulse wave velocity
Secondary study objectives
Change in carotid distensibility index
Change in carotid flow pulsatility index
Change in carotid intimal medial thickness (IMT)

Side effects data

From 2009 Phase 4 trial • 12 Patients • NCT00370838
50%
Tired/sleepy
40%
Anxious
30%
Fatigue
30%
Aggression
20%
Stomache ache
20%
Lethargic
20%
Insomnia
20%
Irritability
10%
Dry mouth
10%
Dizzy
10%
Sleepwalking
10%
Sad/depressed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clonidine
Levetiracetam

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ClonidineExperimental Treatment1 Intervention
0.2 mg/day oral
Group II: HydrochlorothiazideActive Control1 Intervention
37.5 mg/day oral
Group III: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clonidine
FDA approved

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
466 Previous Clinical Trials
893,313 Total Patients Enrolled
Gary Pierce, PhDPrincipal InvestigatorUniversity of Iowa
2 Previous Clinical Trials
77 Total Patients Enrolled

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04423627 — Phase < 1
Aortic Stiffness Research Study Groups: Placebo, Clonidine, Hydrochlorothiazide
Aortic Stiffness Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT04423627 — Phase < 1
Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04423627 — Phase < 1
~11 spots leftby Jun 2025
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