Evaluation of Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mild to Moderate Hypertension
Intervention: LCZ696 (Drug); Sildenafil (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This study is being conducted to investigate the potential for a pharmacokinetic drug-drug
interaction in support of the co-administration of LCZ696 and sildenafil.
Clinical Details
Official title: An Open Label, Three-period, Single Sequence Study to Evaluate the Pharmacokinetic Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate Hypertension
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Pharmacokinetics of LCZ696: Area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCtau)Pharmacokinetics of LCZ696: Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) Pharmacokinetics of LCZ696: Observed minimum plasma concentration following drug administration at steady state (Cmin,ss) Pharmacokinetics of LCZ696: Time to reach the maximum concentration after drug administration (Tmax) Pharmacokinetics of Sildenafil and N-desmethyl-sildenafil: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) Pharmacokinetics of Sildenafil and N-desmethyl-sildenafil: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration Pharmacokinetics of Sildenafil and N-desmethyl-sildenafil: Terminal elimination half-life (T1/2) Pharmacokinetics of Sildenafil and N-desmethyl-sildenafil: Observed maximum plasma concentration following drug administration (Cmax) Pharmacokinetics of Sildenafil and N-desmethyl-sildenafil: Time to reach the maximum concentration after drug administration (Tmax)
Secondary outcome: Number of patients with adverse events, serious adverse events and death
Detailed description:
This study is being conducted to investigate the potential for a pharmacokinetic drug-drug
interaction in support of the co-administration of LCZ696 and sildenafil. Furthermore, this
study is being conducted to explore the potential for a pharmacodynamic interaction as
measured by additive effects on cyclic Guanosine MonoPhosphate (cGMP) in urine and plasma
and on blood pressure.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Male subjects with mild to moderate hypertension, either treated or not currently on
treatment, between age 18 and 65 years of age, and otherwise in good health as determined
by past medical history, physical examination, vital signs, electrocardiogram, and
laboratory tests at screening except for hypertension.
- At screening: systolic blood pressure 120-140 mmHg on therapy, or 140-160 mmHg if
untreated
- At screening: diastolic blood pressure, 70-95 mmHg on therapy, or 90-100 mmHg if
untreated
- Baseline: BP ≥140/90
- Subjects currently on hypertension treatment should be on stable single drug
antihypertensive medication during 2 months prior to screening.
Exclusion Criteria:
- Use of non-antihypertensive prescription drugs, herbal supplements, and/or
over-the-counter (OTC) medication, dietary supplements (vitamins included) within two
(2) weeks prior to initial dosing
- History of documented symptomatic orthostatic hypotension or syncope
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Investigative Site, Berlin 14050, Germany
Additional Information
Starting date: September 2012
Last updated: February 8, 2013
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