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 24, 2014
Last verified: September 2014

August 12, 2013
September 24, 2014
November 2013
August 2014   (final data collection date for primary outcome measure)
  • Percentage of patients experiencing specified adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with systolic blood pressure < 95 mmHg [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with abnormal serum creatinine and doubling of serum creatinine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with Serum potassium > 5.5 mmol/l and ≥ 6.0 mmol/l [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01922089 on ClinicalTrials.gov Archive Site
  • Percentage of patients who achieve treatment success [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who tolerate study medication for at least the last two weeks of the study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
A Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients Comparing Two Titration Regimens

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure With Reduced Ejection Fraction
Drug: LCZ696
LCZ696 50 mg/100 mg/200 mg bid
  • Experimental: Condensed up-titration
    Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
    Intervention: Drug: LCZ696
  • Experimental: Conservative up-titration
    Up-titration to LCZ696 200 mg bid over 6 weeks
    Intervention: Drug: LCZ696
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
499
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria:

  • Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Finland,   Germany,   Hungary,   Italy,   Puerto Rico,   Slovakia,   Spain,   Turkey,   United Kingdom
 
NCT01922089
CLCZ696B2228, 2013-001835-33
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP