Nebivolol in the Supine Hypertension of Autonomic Failure
This study is currently recruiting participants.
Verified May 2012 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01044693
First received: January 6, 2010
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in patients with autonomic failure and supine hypertension.
| Condition | Intervention |
|---|---|
|
Hypertension Pure Autonomic Failure Multiple System Atrophy |
Drug: Placebo Drug: Nebivolol 5 mg Drug: metoprolol tartrate 50 mg Drug: Sildenafil25 mg |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Effect of Nebivolol on Blood Pressure in a Model of Hypertension Sensitive to Potentiation of Nitric Oxide Bioactivity |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple system atrophy
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Nitric oxide
Metoprolol
Metoprolol tartrate
Metoprolol succinate
Nebivolol
Metoprolol fumarate
Sildenafil
Nebivolol Hydrochloride
Sildenafil citrate
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- The fall in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of nebivolol [ Time Frame: 8 pm - 8 am ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urinary volume [ Time Frame: 8 pm - 8 am ] [ Designated as safety issue: No ]
- SBP and DBP 1 minute post standing the following morning [ Time Frame: after 1 min ] [ Designated as safety issue: No ]
- The mean score of Item 1 of the Orthostatic Hypotension Symptom Assessment (OHSA) taken after standing morning following the study [ Time Frame: after 5 min standing or as long as tolerated ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo capsule
Placebo capsule
|
Drug: Placebo
Placebo capsule
Other Name: sugar pill
|
|
Experimental: Nebivolol 5 mg
Nebivolol 5 mg capsule
|
Drug: Nebivolol 5 mg
Nebivolol 5mg single oral dose
Other Name: Bystolic
|
| Active Comparator: Metoprolol tartrate 50 mg |
Drug: metoprolol tartrate 50 mg
metoprolol tartrate 50 mg single oral dose
Other Name: Lopressor
|
| Active Comparator: Sildenafil 25 mg |
Drug: Sildenafil25 mg
Sildenafil 25 mg single oral dose
Other Name: Viagra
|
Detailed Description:
Nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (NO) bioactivity. The contribution of this effect to the pharmacological actions of the drug, however, is difficult to ascertain in normal subjects because of the confounding contribution of the autonomic nervous system. Autonomic failure patients provide a unique model of hypertension devoid of autonomic modulation but sensitive to NO mechanisms. We propose to determine the effect of nebivolol on blood pressure in this patient population. A decrease in blood pressure will imply increased bioactivity of NO. Comparisons will be made with placebo, metoprolol (as a negative control) and sildenafil (as a positive control).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female and aged 18 years or over.
- Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF).
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044693
Contacts
| Contact: Bonnie K Black, RN | 615-322-3304 | adcresearch@vanderbilt.edu |
Locations
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: Italo Biaggioni, MD | |
| Sub-Investigator: David Robertson, MD | |
| Sub-Investigator: Satish Raj, MD | |
| Sub-Investigator: Andre Diedrich, MD, PhD | |
| Sub-Investigator: Alfredo Gamboa, MD | |
| Sub-Investigator: Cyndya Shibao, MD | |
| Sub-Investigator: Bonnie Black, RN | |
| Sub-Investigator: Luis Okamoto, MD | |
| Sub-Investigator: Hossam Mustafa, MD | |
| Sub-Investigator: Cindy Dorminy, MEd, LPN | |
| Sub-Investigator: Amy Arnold, PhD | |
Sponsors and Collaborators
Vanderbilt University
Forest Laboratories
Investigators
| Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University |
More Information
Additional Information:
Publications:
| Responsible Party: | Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01044693 History of Changes |
| Other Study ID Numbers: | 091252 |
| Study First Received: | January 6, 2010 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
supine Hypertension autonomic failure nitric oxide nebivolol |
Additional relevant MeSH terms:
|
Hypertension Multiple System Atrophy Shy-Drager Syndrome Atrophy Pure Autonomic Failure Vascular Diseases Cardiovascular Diseases Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
Hypotension Pathological Conditions, Anatomical Metoprolol Nebivolol Metoprolol succinate Nitric Oxide Sildenafil Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013