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Trial record 41 of 80 for:    "Multiple system atrophy"

Nebivolol in the Supine Hypertension of Autonomic Failure

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ClinicalTrials.gov Identifier: NCT01044693
Recruitment Status : Completed
First Posted : January 8, 2010
Results First Posted : May 1, 2015
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Conditions: Hypertension
Pure Autonomic Failure
Multiple System Atrophy
Interventions: Drug: Placebo
Drug: Nebivolol 5 mg
Drug: metoprolol tartrate 50 mg
Drug: Sildenafil25 mg

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Then Metoprolol Then Sildenafil Then Nebivolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Placebo Then Nebivolol Then Metoprolol Then Sildenafil Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Placebo Then Sildenafil Then Nebivolol Then Metoprolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Placebo Then Sildenafil Then Metoprolol Then Nebivolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Nebivolol Then Placebo Then Metoprolol Then Sildenafil Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Metoprolol Then Sildenafil Then Placebo Then Nebivolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Sildenafil Then Nebivolol Then Placebo Then Metoprolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Metoprolol Then Placebo Then Nebivolol Then Sildenafil Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Nebivolol Then Metoprolol Then Sildenafil Then Placebo Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Metoprolol Then Nebivolol Then Placebo Then Sildenafil Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Metoprolol Then Sildenafil Then Nebivolol Then Placebo Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Sildenafil Then Nebivolol Then Metoprolol Then Placebo Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Sildenafil Then Metoprolol Then Nebivolol Then Placebo Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Nebivolol Then Sildenafil Then Metoprolol Then Placebo Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Nebivolol Then Placebo Then Sildenafil Then Metoprolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
Placebo Then Nebivolol Then Sildenafil Then Metoprolol Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg

Participant Flow:   Overall Study
    Placebo Then Metoprolol Then Sildenafil Then Nebivolol   Placebo Then Nebivolol Then Metoprolol Then Sildenafil   Placebo Then Sildenafil Then Nebivolol Then Metoprolol   Placebo Then Sildenafil Then Metoprolol Then Nebivolol   Nebivolol Then Placebo Then Metoprolol Then Sildenafil   Metoprolol Then Sildenafil Then Placebo Then Nebivolol   Sildenafil Then Nebivolol Then Placebo Then Metoprolol   Metoprolol Then Placebo Then Nebivolol Then Sildenafil   Nebivolol Then Metoprolol Then Sildenafil Then Placebo   Metoprolol Then Nebivolol Then Placebo Then Sildenafil   Metoprolol Then Sildenafil Then Nebivolol Then Placebo   Sildenafil Then Nebivolol Then Metoprolol Then Placebo   Sildenafil Then Metoprolol Then Nebivolol Then Placebo   Nebivolol Then Sildenafil Then Metoprolol Then Placebo   Nebivolol Then Placebo Then Sildenafil Then Metoprolol   Placebo Then Nebivolol Then Sildenafil Then Metoprolol
STARTED   3   1   1   1   1   2   1   1   1   1   1   1   2   1   1   1 
COMPLETED   3   1   1   1   1   2   1   1   1   1   1   1   2   1   1   1 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients with primary forms of autonomic failure and supine hypertension

Reporting Groups
  Description
All Study Participants Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 69  (8) 
Gender 
[Units: Participants]
 
Female   6 
Male   14 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 25.6  (3.2) 
Duration of disease 
[Units: Years]
Mean (Standard Deviation)
 8  (6) 
Diagnosis 
[Units: Participants]
 
Pure autonomic failure   10 
Parkinson Disease with autonomic failure   4 
Multiple System Atrophy   6 
Medical history of essential hypertension 
[Units: Participants]
 
yes   4 
No   16 
Systolic BP, supine 
[Units: Mm Hg]
Mean (Standard Deviation)
 169  (24) 
Systolic BP, upright 
[Units: Mm Hg]
Mean (Standard Deviation)
 83  (25) 
Heart rate, supine 
[Units: Bpm]
Mean (Standard Deviation)
 68  (10) 
Heart rate, upright 
[Units: Bpm]
Mean (Standard Deviation)
 83  (15) 
Plasma norepinephrine, supine 
[Units: pg/mL]
Mean (Standard Deviation)
 136  (98) 
Plasma norepinephrine, upright 
[Units: pg/mL]
Mean (Standard Deviation)
 253  (209) 


  Outcome Measures

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Italo Biaggioni MD
Organization: Vanderbilt University
phone: 615-936-3420
e-mail: italo.biaggioni@vanderbilt.edu


Publications:

Responsible Party: Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01044693     History of Changes
Other Study ID Numbers: 091252
First Submitted: January 6, 2010
First Posted: January 8, 2010
Results First Submitted: April 14, 2015
Results First Posted: May 1, 2015
Last Update Posted: May 1, 2015