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Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Candesartan+HCTZ - Phase 1 (Drug); Aliskiren+HCTZ - Phase 2 (Drug); Aliskiren+HCTZ+amlodipine - Phase 3 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Summary

This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.

Clinical Details

Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

Secondary outcome:

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study

Change in Sitting Pulse Pressure During the Core Phase of the Study

Change in Sitting Pulse Rate During the Core Phase of the Study

Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study

Change in Sitting Pulse Pressure During the Extension Phase of the Study

Change in Sitting Pulse Rate During the Extension Phase of the Study

Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

Detailed description: Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria for Core Study:

- Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg

Inclusion criteria for the Extension:

- msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Exclusion Criteria for Core Study:

- Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood

pressure ≥ 180 mmHg

- Patients with prior stroke, hypertensive encephalopathy or heart attack

- Patients with type 1 diabetes mellitus

- Patients with type 2 diabetes mellitus with poor glucose control

Exclusion criteria for the Extension:

- Premature discontinuation in the core study or failure to comply with the core study

protocol

- History of hypersensitivity to any of the study drugs or to drugs with similar

chemical structures, known or suspected contraindications to diuretics as described

in the SmPC (particularly amlodipine 5 mg), e. g. severe hypotension, shock -

including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e. g. significant aortic stenosis)

- Any patient that the investigator decides should not participate in the extension

study for medical reasons Other protocol-defined inclusion/exclusion criteria applied to the study.

Locations and Contacts

Investigative Site, Chemnitz, Germany
Additional Information

Starting date: March 2009
Last updated: May 4, 2011

Page last updated: August 23, 2015

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