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.

Last updated: February 21, 2017
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

High Blood Pressure (Hypertension)

High Blood Pressure (Hypertension - Pediatric)

Stress

Treatment

N/A

Clinical Study ID

NCT00343551
CSPP100A2351
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beforeapplication of Ambulatory Blood Pressure Measurement device At Visit 3 : 24-hr MeanAmbulatory Diastolic Blood Pressure ≥ 85 mmHg

  • Patient must have an absolute difference of ≤ 10 mmHg in their office Mean SittingDiastolic Blood Pressure between Visit 2 and 3.

  • Male or female patients are eligible. Female patients must be either post-menopausalfor at least one year, surgically sterile or using effective contraceptive methodssuch as oral contraceptives, barrier method with spermicide or an intrauterine device.Reliable contraception should be maintained throughout the study and for 7 days afterstudy drug discontinuation.

  • Patients who are eligible and able to participate in the study, and who consent to doso after the purpose and nature of the investigation has been clearly explained tothem (written informed consent).

Exclusion

Exclusion Criteria:

  • Severe hypertension [Office Mean Sitting Diastolic Blood Pressure ≥ 110 mmHg and/oroffice 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 percutaneouscoronary intervention (PCI) during the 12 months prior to Visit 1.

  • Known or suspected contraindications to the study medications, including history ofallergy to ACE-Inhibitors or ARBs.

  • Upper arm circumference > 42 cm.

  • Third shift or night workers. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 654
Study Start date:
May 01, 2006
Estimated Completion Date:

Connect with a study center

  • Investigative Centers,
    Germany

    Site Not Available

  • Novartis Pharmaceuticals

    Basel,
    Switzerland

    Site Not Available

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