Nebivolol in the Supine Hypertension of Autonomic Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

NCT00648895

Hypertension

COMPLETED PHASE3

Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

NCT01041287

Hypertension

COMPLETED PHASE4

Nebivolol and the Endothelin (ET)-1 System

NCT01395329

Prehypertension Hypertension

COMPLETED PHASE4

The Role of Endothelin in the Supine Hypertension of Autonomic Failure

NCT01119417

Hypertension Pure Autonomic Failure Multiple System Atrophy

WITHDRAWN PHASE1

Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients

NCT01502787

Hypertension

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Pure Autonomic Failure Multiple System Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule

Nebivolol 5 mg

Nebivolol 5 mg capsule

Group Type EXPERIMENTAL

Nebivolol 5 mg

Intervention Type DRUG

Nebivolol 5mg single oral dose

Metoprolol tartrate 50 mg

Metoprolol tartrate 50 mg single oral dose

Group Type ACTIVE_COMPARATOR

metoprolol tartrate 50 mg

Intervention Type DRUG

metoprolol tartrate 50 mg single oral dose

Sildenafil 25 mg

Sildenafil 25 mg single oral dose

Group Type ACTIVE_COMPARATOR

Sildenafil25 mg

Intervention Type DRUG

Sildenafil 25 mg single oral dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo capsule

Intervention Type DRUG

Nebivolol 5 mg

Nebivolol 5mg single oral dose

Intervention Type DRUG

metoprolol tartrate 50 mg

metoprolol tartrate 50 mg single oral dose

Intervention Type DRUG

Sildenafil25 mg

Sildenafil 25 mg single oral dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sugar pill Bystolic Lopressor Viagra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No