Evaluation of Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01601470
First received: May 16, 2012
Last updated: October 6, 2015
Last verified: October 2015
Results First Received: July 11, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Mild to Moderate Hypertension
Interventions: Drug: LCZ696
Drug: Sildenafil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.

Participant Flow for 3 periods

Period 1:   Period 1 - Sildenafil
    Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil  
STARTED     28  
PK Analysis Set     28  
Safety Set     28  
COMPLETED     28  
NOT COMPLETED     0  

Period 2:   Period 2 - LCZ696
    Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil  
STARTED     28  
PK Analysis Set     27  
Safety Set     27  
COMPLETED     27  
NOT COMPLETED     1  
Physician Decision                 1  

Period 3:   Period 3 - LCZ696+Sildenafil
    Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil  
STARTED     27  
PK Analysis Set     27  
Safety Set     27  
COMPLETED     27  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.

Baseline Measures
    Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil  
Number of Participants  
[units: participants]
  28  
Age  
[units: Years]
Mean (Standard Deviation)
  51.8  (8.5)  
Gender  
[units: Participants]
 
Female     0  
Male     28  



  Outcome Measures
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1.  Primary:   Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

2.  Primary:   Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

3.  Primary:   Minimum Plasma Concentration Following Drug Administration at Steady State (Cmin,ss) of LCZ696 Analytes (AHU377, LBQ696 and Valsartan)   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

4.  Primary:   Time to Reach the Maximum Concentration After Drug Administration (Tmax) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

5.  Primary:   Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sildenafil and N-desmethyl-sildenafil Analytes   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

6.  Primary:   Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sildenafil and N-desmethyl-sildenafil Analytes   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

7.  Primary:   Terminal Elimination Half-life (T1/2) of Sildenafil and N-desmethyl-sildenafil Analytes   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

8.  Primary:   Maximum Plasma Concentration Following Drug Administration (Cmax) of Sildenafil and N-desmethyl-sildenafil Analytes   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

9.  Primary:   Time to Reach the Maximum Concentration After Drug Administration (Tmax) of Sildenafil and N-desmethyl-sildenafil Analytes   [ Time Frame: From pre-dose on day 1 until 12 hours post dose on day 8 ]

10.  Secondary:   Adverse Events, Serious Adverse Events and Deaths Were Monitored From Screening to End of Study   [ Time Frame: From the screening visit until 30 days past the final study assessment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01601470     History of Changes
Other Study ID Numbers: CLCZ696B2225
2012-001632-64 ( EudraCT Number )
Study First Received: May 16, 2012
Results First Received: July 11, 2015
Last Updated: October 6, 2015
Health Authority: Germany: Federal Institute for Drugs and Medicinal Products