A Phase 2 interventional study of Clonidine and Hydrochlorothiazide in Obesity, Prehypertension and Hypertension, sponsored by Gary L. Pierce. Terminated at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Gary L. Pierce · Phase 2, Interventional, and Treatment
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:
I
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 33 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Gary L. Pierce is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral 0.2 mg/day (0.1 mg bid)for 4 weeks
Drug: Clonidine
Oral, 12.5 mg/day qd, 4 weeks
Drug: Hydrochlorothiazide
Placebo
Drug: Placebo
Also known as: Catapress
Aortic Stiffness
Carotid-femoral pulse wave velocity (PWV)
Time frame: 4 weeks
24 Hour Average Systolic Blood Pressure
24 hour ambulatory systolic blood pressure
Time frame: 4 weeks
| Milestone | Clonidine | Hydrochlorothiazide | Placebo |
|---|---|---|---|
| Started | 11 | 11 | 11 |
| Completed | 10 | 11 | 11 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
Carotid-femoral pulse wave velocity (PWV)
| meters/sec | Clonidine | Hydrochlorothiazide | Placebo |
|---|---|---|---|
| Baseline | 7.9 ± 0.7 | 7.0 ± 0.4 | 8.1 ± 1.0 |
| 4 weeks | 7.3 ± 0.6 | 7.0 ± 0.3 | 8.0 ± 1.2 |
24 hour ambulatory systolic blood pressure
| mmHg | Clonidine | Hydrochlorothiazide | Placebo |
|---|---|---|---|
| Baseline | 133 ± 3 | 135 ± 2 | 133 ± 2 |
| 4 weeks | 126 ± 3 | 131 ± 2 | 134 ± 2 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clonidine | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) |
| Hydrochlorothiazide | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Clonidine | Hydrochlorothiazide | Placebo |
|---|---|---|---|
| Mild hypotensionCardiac disorders | 1/10 | 0/11 | 0/11 |
| Age, Categorical(Participants) | Clonidine | Hydrochlorothiazide | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 11 | 10 | 31 |
| >=65 years | 1 | 0 | 1 | 2 |
| Age, Continuous(years) | Clonidine | Hydrochlorothiazide | Placebo | Total |
|---|---|---|---|---|
| Mean | 41 ± 18 | 31 ± 10 | 37 ± 19 | 35 ± 16 |
| Sex: Female, Male(Participants) | Clonidine | Hydrochlorothiazide | Placebo | Total |
|---|---|---|---|---|
| Female | 2 | 1 | 5 | 8 |
| Male | 9 | 10 | 6 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Clonidine | Hydrochlorothiazide | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 2 |
| Not Hispanic or Latino | 10 | 11 | 10 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Clonidine | Hydrochlorothiazide | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Asian | 2 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 1 | 5 |
| White | 6 | 6 | 10 | 22 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Clonidine | Hydrochlorothiazide | Placebo | Total |
|---|---|---|---|---|
| United States | 11 | 11 | 11 | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2013 to primary completion in Jun 2020, 80 months.
Results were first posted in Apr 2023, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Clonidine
Gary L. Pierce