Nebivolol in the Supine Hypertension of Autonomic Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01044693
• Date of registration: 06/01/2010
• Prospective Registration: No
• Primary sponsor: Vanderbilt University
• Public title: Nebivolol in the Supine Hypertension of Autonomic Failure
• Scientific title: Effect of Nebivolol on Blood Pressure in a Model of Hypertension Sensitive to Potentiation of Nitric Oxide Bioactivity
• Date of first enrolment: January 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01044693
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Italo Biaggioni, MD
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female and aged 18 years or over.

- Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic
Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).

- A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic
blood pressure of at least 10 mmHg, within 3 minutes after standing.

- Supine hypertension, defined as a systolic blood pressure >150 mm Hg or diastolic
blood pressure > 90 mm Hg.

- Provide written informed consent to participate in the study and understand that they
may withdraw their consent at any time without prejudice to their future medical care.

Exclusion Criteria:

- Have changed dose, frequency and or type of prescribed medication, within two weeks of
study start.

- Women of childbearing potential who are not using a medically accepted contraception.

- Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or
renal illness.

- Diabetes mellitus or insipidus.

- In the investigator's opinion, have clinically significant abnormalities on clinical
examination or laboratory testing.

- In the investigator's opinion, are unable to adequately co-operate because of
individual or family situation.

- In the investigator's opinion, are suffering from a mental disorder that interferes
with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major
depression, dementia.

- Are not able or willing to comply with the study requirements for the duration of the
study.

- Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking
scheduled or as needed nitrates and persons on drugs with alpha-blocking potential
(e.g. tamsulosin).



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pure Autonomic Failure

Hypertension

Multiple System Atrophy

Intervention(s)

Drug: Nebivolol 5 mg

Drug: Placebo

Drug: metoprolol tartrate 50 mg

Drug: Sildenafil25 mg

Primary Outcome(s)

Change in Systolic Blood Pressure During the Night [Time Frame: 8 pm - 8 am]

Secondary Outcome(s)

Orthostatic Tolerance the Following Morning [Time Frame: 10 min standing]

Change in Heart Rate During the Night [Time Frame: 8 pm - 8 am]

Nocturnal Urinary Sodium Excretion [Time Frame: 8 pm - 8 am]

Secondary ID(s)

091252

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories

Results

• Results available: Yes
• Date Posted: 01/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01044693