DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017