Expired Study
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East Hanover, New Jersey


Purpose:

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.


Criteria:

Inclusion Criteria: 1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study. 2. absence of ongoing severe adverse events at Visit 10.


Study is Available At:


Original ID:

CSPP100A2302E1


NCT ID:

NCT00171405


Secondary ID:


Study Acronym:


Brief Title:

A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg


Official Title:

A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hype


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model: Si


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

250


Enrollment Type:


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:June 2005
Completion Date:February 2006
Completion Type:Actual
Primary Completion Date:February 2006
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 16, 2016
First Received Date:August 24, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Blood pressure less than 140/90 mmHg
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:aliskiren

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.2165/11590280-000000000-00000.
PMID:22035463

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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