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.

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343551
• Other study ID #: CSPP100A2351
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2006
• Last updated: February 21, 2017
• Start date: May 2006

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. primary completion date: January 2007
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Aliskiren

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, aliskiren 300 mg versus irbesartan 300mg.
Primary	from baseline.
Primary	Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, ramipril 10 mg versus irbesartan 300mg.
Secondary	efficacy on mean 24 hour ambulatory systolic blood pressure (MASBP) change
Secondary	from baseline following a missed dose
Secondary	efficacy on daytime and nighttime MASBP and MADBP change from baseline following a missed dose
Secondary	efficacy on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group.
Secondary	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.
Secondary	safety and tolerability

External Links

•   Results for CSPP100A2351 from the Novartis Clinical Trials website