RESEARCH STUDY: Midodrine Hydrochloride (ProAmatine)

[Guest guest]

Note this study is taking place at 15 different centers in the US.

Regards,

Pam

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http://www.centerwatch.com/patient/studies/stu37732.html

Summary: Do you often suffer from dizziness, lightheadedness, fainting and

weakness in the standing/upright position?

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover

Study to Assess the Clinical Benefit of Midodrine Hydrochloride (ProAmatine

®) in Patients with Neurogenic Orthostatic Hypotension.

We are seeking male and female patients to voluntarily take part in a

clinical research study. Patients must be aged 18 or older and diagnosed

with symptomatic orthostatic hypotension (low blood pressure while in the

upright position) due to Parkinson’s disease, multiple system atrophy, pure

autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic

hypotension). Symptoms of low blood pressure include dizziness,

lightheadedness, changes in vision and generalized weakness upon standing.

The main effect of the drug being studied is to increase blood pressure in

the upright position so symptoms will decrease.

The purpose of this clinical study is to further assess the clinical benefit

of midodrine hydrochloride (ProAmatine ®), an approved treatment for

orthostatic hypotension. During the course of the study, participants will

receive either ProAmatine ® or a placebo. Assessments will be made using

questionnaires that measure symptom and activity levels. Blood pressure in

the lying down and standing positions will be measured at each visit.

You should be aware that because ProAmatine ® can cause marked elevation of

blood pressure while in the lying down position, it should be used in

patients whose lives are considerably impaired despite standard clinical

care. The indication for use of ProAmatine ® in the treatment of symptomatic

orthostatic hypotension is based primarily on a change in a surrogate marker

of effectiveness, that is, an increase in systolic blood pressure measured

one minute after standing, a surrogate marker considered likely to

correspond to a clinical benefit. At present, however, clinical benefits of

ProAmatine ®, principally improved ability to carry out activities of daily

living, have not been verified.

ProAmatine ® is contraindicated in patients with severe organic heart

disease, acute renal disease, urinary retention, pheochromocytoma or

thyrotoxicisis. ProAmatine ® should not be used in patients with persistent

and excessive supine hypertension.

Please consult with your physician to see whether you might benefit from

participation in this study.

The length of this study is approximately 8 weeks with a minimum of 7

required office visits. Additional office visits may be necessary.

Individual patient participation could be longer or shorter depending on the

number of site visits needed. Patients will receive all study-related

procedures at no charge and will be financially compensated for completed

site visits.

Contact:

Barbara Dick, RN

Neurological Associates of Delaware Valley

One Medical Center Blvd.

Upland, PA 19013

Telephone:

Email: bdickrn@...

Laurel or Greg

Diabetes & Glandular Disease Research Associates, PA

Located in:

San , TX

Telephone: ext. 1454 or ext. 1077

Donna Regula

Dr. Harry Pepe & Associates, Inc.

6248 Miramar Parkway

Miramar, FL 33023

Telephone:

Fax:

Connie S. Bolyard, RN

West Virginia University

Department of Medicine

Section of Endocrinology and Metabolism

C. Bryd Health Science Center

PO Box 9159

town, WV 26506

Telephone:

Janice Stack

s Hopkins Hospital

Located in:

Baltimore, MD

Telephone:

Clinton Corder, PhD, MD

COR Clinical Research, LLC

1211 N. Shartel, Suite 802

Oklahoma City,, OK 73103

Telephone:

Fax:

Email: ccorder@...

Suzanne Lash

Suncoast Neuroscience Associates, Inc.

Located in:

St. sburg, FL

Telephone:

Vendt, RN

Monarch Medical Research

6161 Kempsville Circle, Suite 315

Norfolk, VA 23502

Telephone:

Study Coordinator

Michigan Pain and Neurological Institute

Located in:

Ann Arbor, MI

Telephone: ext. 4

Email: MHNIINFO@...

Norma Skillings, RN, CRC, Carol Clayton, RN, CCRC or Dr. Sauter

Westmoreland Neurology Associates Inc.

327 West Pittsburgh St.

Greensburg, PA 15601

Telephone: or

Fax:

Email: sauter@...

C. , M.D., Ph.D.

North Alabama Neuroscience Research

1104 Monroe Street

Huntsville, AL 35801

Telephone:

Economou & Associates, LTD

1725 W. on Street, Suite 774

Chicago, IL 60612

Telephone:

Dyan Serna

Medical College of Ohio

3000 Arlington Ave.

Toledo, OH 43614

Telephone:

Fax:

Email: ccorder@...

Dr. Bloomfield, Director of the Syncope Center

NY Presbyterian Hospital

630 W. 168th St.

New York, NY 10032

Telephone:

Fax:

Email: palumbo@...

ine LeBlanc

Dartmouth Hitchcock Medical Center

Department of Neurology

1 Medical Center Drive

Lebanon, NH 03756

Telephone:

Email: ine.R.LeBlanc@...