Phase 2 Completed N=28

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

Mild to Moderate Hypertension

Source: ClinicalTrials.gov NCT01601470 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes — 3700; 147000; 23600 h*ng/mL

Summary

This study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in support of the co-administration of LCZ696 and sildenafil.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes	3700; 147000; 23600	—
PRIMARY Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)	2310; 14000; 3350	—
PRIMARY Minimum Plasma Concentration Following Drug Administration at Steady State (Cmin,ss) of LCZ696 Analytes (AHU377, LBQ696 and Valsartan)	0.0; 2170; 197	—
PRIMARY Time to Reach the Maximum Concentration After Drug Administration (Tmax) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)	1.00; 3.00; 2.00	—
PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sildenafil and N-desmethyl-sildenafil Analytes	629; 325	—
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	612; 305	—
PRIMARY Terminal Elimination Half-life (T1/2) of Sildenafil and N-desmethyl-sildenafil Analytes	3.84; 6.20	—
PRIMARY Maximum Plasma Concentration Following Drug Administration (Cmax) of Sildenafil and N-desmethyl-sildenafil Analytes	189; 84.6	—
PRIMARY Time to Reach the Maximum Concentration After Drug Administration (Tmax) of Sildenafil and N-desmethyl-sildenafil Analytes	1.00; 1.00	—
SECONDARY Adverse Events, Serious Adverse Events and Deaths Were Monitored From Screening to End of Study	17; 0; 0	—

Eligibility 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.
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;

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

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01601470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.