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Completed

NCT Number: NCT00706134

Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female outpatients 65 years of age and older.
  • 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).
  • At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion criteria

  • Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
  • History or evidence of a secondary form of hypertension.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
  • Current diagnosis of heart failure (NYHA Class II-IV).
  • History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
  • Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Treatment and study plan

Placebo

Drug

Placebo tablet taken once daily in the morning with a light meal.

Aliskiren 75 mg

Drug

Aliskiren 75 mg tablet taken once daily in the morning with a light meal.

Aliskiren 150 mg

Drug

Aliskiren 150 mg tablet taken once daily in the morning with a light meal.

Aliskiren 300 mg

Drug

Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Primary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)

    Time frame: Baseline to end of study (Week 8)

Secondary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

    Time frame: Baseline to end of study (Week 8)

  2. Percentage of Patients Achieving Systolic Blood Pressure Response

    Time frame: Baseline to end of study (Week 8)

    Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.

  3. Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study

    Time frame: Baseline to end of study (Week 8)

    Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.

  4. Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)

    Time frame: Baseline to end of study (Week 8)

    Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.

  5. Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)

    Time frame: Baseline to end of study (week 8)

    The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2008
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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