Trial Outcomes & Findings for Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation (NCT NCT01235910)

Results Overview

The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

7 days, 14 days, 30 days (End of Study)

Results posted on

2018-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Aliskiren Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aliskiren n=1 Participants Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	58 years STANDARD_DEVIATION 0 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 7 days, 14 days, 30 days (End of Study)

The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.

Outcome measures

Outcome measures
Measure	Aliskiren n=1 Participants Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)	NA ng*h/ml/mg Values are not available for this measure. Study was stopped due to difficulty finding patients meeting strict inclusion criteria. One patient was started on the study drug. Therefore, we did not analyze any aliskiren PK (e.g. AUC) in this study.

SECONDARY outcome

Timeframe: 2 weeks

Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any PK (e.g.(AUCs) for this study.

Outcome measures

Outcome measures
Measure	Aliskiren n=1 Participants Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Aliskiren Plasma Concentrations	NA ng*h/ml/mg Values are not available for this measure. Study was stopped due to difficulty finding patients meeting strict inclusion criteria. One patient was started on the study drug. Therefore, we did not analyze any aliskiren PK (e.g. AUC) in this study.

SECONDARY outcome

Timeframe: 2 weeks

The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any blood pressure for this study.

Outcome measures

Outcome measures
Measure	Aliskiren n=1 Participants Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Blood Pressure	NA mmHg Values are not available for this measure. Study was stopped due to difficulty finding patients meeting strict inclusion criteria. One patient was started on the study drug. Therefore, we did not analyze any blood pressure in this study.

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christina Aquilante, Pharm.D.

University of Colorado

Phone: 303-724-6126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place