Treatment of Orthostatic Hypotension

NCT00581477 | Terminated Phase 2 Results

• 2 other identifiers: 030750P01HL056693
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.

Conditions

Autonomic Nervous System Diseases; Orthostatic Hypotension; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Intolerance

Keywords

autonomic nervous system diseases; blood pressure; congenital; orthostasis; catecholamines

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure With Standing

  The difference between upright and supine systolic blood pressures (dSBP; upright - supine) was calculated for each patient at 60-240 minutes after each dose of droxidopa. For each post-dose timepoint and study day, the average of up to three blood pressure readings per droxidopa dose was calculated. Dosing is individualized for each patient based upon how well the drug is tolerated and the degree of improvement in orthostatic vital signs and symptoms following drug administration. The dosages administered, as well as the number of timepoints and days, therefore, varied between patients.

  Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.

Study Arms (1)

Droxidopa

EXPERIMENTAL

Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were administered Droxidopa doses of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg or 300 mg up to three times daily. Supine and upright blood pressures were subsequently measured 60 to 240 minutes post-dose.

Drug: Droxidopa Oral Product

Interventions

Droxidopa Oral Product DRUG

Droxidopa administered in increasing dosages up to 300 mg

Also known as: L-DOPS

Droxidopa

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
• non-smokers
• drug-free
• able to give informed consent
• free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

You may not qualify if:

• medications affecting the autonomic nervous system
• any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
• anemia (Hct \< 30)
• women of childbearing age who are pregnant or nursing
• smokers

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Autonomic Nervous System Diseases; Hypotension, Orthostatic; dopamine beta hydroxylase deficiency; Orthostatic Intolerance; Dizziness

Interventions

Droxidopa

Condition Hierarchy (Ancestors)

Nervous System Diseases; Primary Dysautonomias; Hypotension; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Intervention Hierarchy (Ancestors)

Norepinephrine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Alfredo Gamboa MD
• Organization: Vanderbilt University Medical Center

alfredo.gamboa@vumc.org

6158751003

Study Officials

• David Robertson, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: Although the study was designed as a potential trial of multiple medications, plus placebo, in actuality it served as a means of safely determining the optimal dose of Droxidopa for our patients with Dopamine beta-Hydroxylase Deficiency to take at home. Before each dose of Droxidopa, blood pressure and heart rate were measured for 30 minutes. At 60 or 120 minutes after dosing, blood pressure was also measured after 5 minutes of lying down and 5 minutes of sitting or standing. These measurements were used to calculate the orthostatic change in systolic blood pressure, the primary outcome.

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: December 27, 2007
• Study Start: January 1, 2004
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Locations

US (1)