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

Hypertension Clinical Trial

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 Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171405
• Other study ID #: CSPP100A2302E1
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2005
• Last updated: November 16, 2016
• Start date: June 2005
• Est. completion date: February 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• aliskiren

Locations

Country	Name	City	State
Belgium	Investigative Site	Deurne
Canada	Investigative Site	Ste-Fov
Germany	Investigative Site	Krassel
Italy	Investigative Site	Broni
Netherlands	Investigative Site	Rotterdam
Peru	Investigative Site	Lima
Russian Federation	Investigative Site	Moscow
Switzerland	Investigative Site	Basel
United Kingdom	Investigative Site	London
United States	Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Italy,  Netherlands,  Peru,  Russian Federation,  Switzerland,  United Kingdom, 

References & Publications (1)

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-grou — View Citation

Outcome

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

External Links

•   Results for CSPP100A2302E1 from the Novartis Clinical Trials website