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. - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00343551

Purpose

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.

Condition	Intervention	Phase
Essential Hypertension	Drug: Aliskiren	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril Irbesartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	654
Study Start Date:	May 2006
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343551

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CSPP100A2351
Study First Received:	June 22, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00343551 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Novartis:

Hypertension, ambulatory blood pressure, missed dose, aliskiren

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Irbesartan
Vascular Diseases

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010