Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients (TITRATION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01922089
First received: August 12, 2013
Last updated: September 16, 2015
Last verified: September 2015
Results First Received: July 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Failure With Reduced Ejection Fraction
Intervention: Drug: LCZ696

  Participant Flow
  Hide 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
LCZ696 Condensed Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
LCZ696 Conservative Up-titration to LCZ696 200 mg bid over 6 weeks

Participant Flow:   Overall Study
    LCZ696 Condensed   LCZ696 Conservative
STARTED   247   251 
Safety Set   246   251 
COMPLETED   208   221 
NOT COMPLETED   39   30 
Adverse Event                18                13 
Protocol Deviation                10                7 
Withdrawal by Subject                3                4 
administrative problems                4                1 
Physician Decision                2                3 
Death                2                1 
Lost to Follow-up                0                1 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
LCZ696 Condensed Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
LCZ696 Conservative Up-titration to LCZ696 200 mg bid over 6 weeks
Total Total of all reporting groups

Baseline Measures
   LCZ696 Condensed   LCZ696 Conservative   Total 
Overall Participants Analyzed 
[Units: Participants]
 247   251   498 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (11.86)   63.8  (10.94)   64.0  (11.39) 
Gender 
[Units: Participants]
     
Female   56   50   106 
Male   191   201   392 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)   [ Time Frame: 12 weeks ]

3.  Secondary:   Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01922089     History of Changes
Other Study ID Numbers: CLCZ696B2228
2013-001835-33 ( EudraCT Number )
Study First Received: August 12, 2013
Results First Received: July 16, 2015
Last Updated: September 16, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Slovak Republic: Ethics Committee
Italy: Ministry of Health
Spain: Ministry of Health
Turkey: Ministry of Health
Bulgaria: Ministry of Health
Hungary: Institutional Ethics Committee
Finland: Ministry of Social Affairs and Health
Norway: Norwegian Medicines Agency