Effect of Light Meal on Pharmacokinetic and Pharmacodynam... | NCT00933920

Studies
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension

NCT00933920

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

124Actual

Phase

Phase 1

Conditions

Hypertension

Interventions

Aliskiren
Aliskiren

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Not provided

First Submitted Date

Jul 3, 2009

First Submission Date that Met QC Criteria

Jul 6, 2009

First Posted Date

Jul 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 21, 2020Actual

Description Module

Brief Summary

The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Label	Type	Description	Intervention Names
Fed Group	Active Comparator		Drug: Aliskiren
Fasted group	Active Comparator		Drug: Aliskiren

Name	Type	Description	Arm Group Labels	Other Names
Aliskiren	Drug		Fed Group
Aliskiren

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.		28 Days

Secondary Outcomes

Measure	Description	Time Frame
Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal		28 Days
Assess safety and tolerability of aliskiren when given with and without light meal		28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
Patients who are eligible and able to participate in the study

Exclusion criteria:

Severe hypertension
Secondary form of hypertension.
Type 1 or type 2 diabetes mellitus
Serum potassium out side laboratory reference range
Any history of hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		Coimbatore			India
Novartis Investigative Site

References Module

Citations

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Type	Description	Link
CTRI/2009/091/000287
26-06-2009