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Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aliskiren
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, ambulatory blood pressure, missed dose, aliskiren

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Outpatients 18 years of age and older. Patients must meet following blood pressure criteria: At Visit 2 : Office Mean Sitting Diastolic Blood Pressure ≥ 90 mmHg and < 110 mmHg At Visit 3 : Office Mean Sitting Diastolic Blood Pressure ≥ 95 mmHg and < 110 mmHg before application of Ambulatory Blood Pressure Measurement device At Visit 3 : 24-hr Mean Ambulatory Diastolic Blood Pressure ≥ 85 mmHg Patient must have an absolute difference of ≤ 10 mmHg in their office Mean Sitting Diastolic Blood Pressure between Visit 2 and 3. Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). Exclusion Criteria: Severe hypertension [Office Mean Sitting Diastolic Blood Pressure ≥ 110 mmHg and/or office mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg]. Current diagnosis of heart failure (NYHA Class II-IV). History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors or ARBs. Upper arm circumference > 42 cm. Third shift or night workers. Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, aliskiren 300 mg versus irbesartan 300mg.
from baseline.
Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, ramipril 10 mg versus irbesartan 300mg.

Secondary Outcome Measures

efficacy on mean 24 hour ambulatory systolic blood pressure (MASBP) change
from baseline following a missed dose
efficacy on daytime and nighttime MASBP and MADBP change from baseline following a missed dose
efficacy on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group.
efficacy on the daytime and nighttime MASBP and MADBP change from baseline, following the last active dose prior to introducing a missed dose in any treatment group.
safety and tolerability

Full Information

First Posted
June 22, 2006
Last Updated
February 21, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00343551
Brief Title
Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.
Official Title
A Nine-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg Compared to Irbesartan 300 mg and Ramipril 10 mg in the Setting of a Missed Dose in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy (blood pressure lowering effect) and safety of aliskiren given to hypertensive patients after a missed dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, ambulatory blood pressure, missed dose, aliskiren

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
654 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aliskiren
Primary Outcome Measure Information:
Title
Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, aliskiren 300 mg versus irbesartan 300mg.
Title
from baseline.
Title
Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, ramipril 10 mg versus irbesartan 300mg.
Secondary Outcome Measure Information:
Title
efficacy on mean 24 hour ambulatory systolic blood pressure (MASBP) change
Title
from baseline following a missed dose
Title
efficacy on daytime and nighttime MASBP and MADBP change from baseline following a missed dose
Title
efficacy on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group.
Title
efficacy on the daytime and nighttime MASBP and MADBP change from baseline, following the last active dose prior to introducing a missed dose in any treatment group.
Title
safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Outpatients 18 years of age and older. Patients must meet following blood pressure criteria: At Visit 2 : Office Mean Sitting Diastolic Blood Pressure ≥ 90 mmHg and < 110 mmHg At Visit 3 : Office Mean Sitting Diastolic Blood Pressure ≥ 95 mmHg and < 110 mmHg before application of Ambulatory Blood Pressure Measurement device At Visit 3 : 24-hr Mean Ambulatory Diastolic Blood Pressure ≥ 85 mmHg Patient must have an absolute difference of ≤ 10 mmHg in their office Mean Sitting Diastolic Blood Pressure between Visit 2 and 3. Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). Exclusion Criteria: Severe hypertension [Office Mean Sitting Diastolic Blood Pressure ≥ 110 mmHg and/or office mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg]. Current diagnosis of heart failure (NYHA Class II-IV). History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors or ARBs. Upper arm circumference > 42 cm. Third shift or night workers. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
City
Investigative Centers
Country
Germany
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19458624
Citation
Palatini P, Jung W, Shlyakhto E, Botha J, Bush C, Keefe DL. Maintenance of blood-pressure-lowering effect following a missed dose of aliskiren, irbesartan or ramipril: results of a randomized, double-blind study. J Hum Hypertens. 2010 Feb;24(2):93-103. doi: 10.1038/jhh.2009.38. Epub 2009 May 21.
Results Reference
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Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.

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