- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00797316
Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (AIMS)
March 8, 2011 updated by: Novartis
An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure [msSBP] ≥ 160 mm Hg and < 200 mm Hg).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
532
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Male or female outpatients ≥ 18 years old.
- Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).
Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:
- Abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
- Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
- Current HDL- Cholesterol <40 mg/dL in men and <50 mg/dL in women or medical treatment for this condition.
- Fasting glucose >100 mg/dL and <126 mg/dL
Exclusion Criteria:
- Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
- History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
- History or evidence of secondary form of hypertension.
- Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- Patients on 4 or more antihypertensive medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aliskiren plus Hydrochlorothiazide
Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week.
Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg).
Medication was taken once daily in oral form.
|
Aliskiren 150 mg or 300 mg taken once daily in oral form
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.
|
Active Comparator: Aliskiren
Aliskiren (150 mg) for one week.
Subsequently up-titrated to Aliskiren (300 mg).
Medication was taken once daily in oral form.
|
Aliskiren 150 mg or 300 mg taken once daily in oral form
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)
Time Frame: Baseline and Week 8
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)
Time Frame: 8 weeks
|
8 weeks
|
|
Percentage of Participants With Blood Pressure Response at Week 8
Time Frame: 8 weeks
|
Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.
|
8 weeks
|
Percentage of Patients Achieving Blood Pressure Control at Week 8
Time Frame: 8 weeks
|
Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.
|
8 weeks
|
Change From Baseline to Week 8 in Pulse Pressure
Time Frame: Baseline and Week 8
|
Baseline and Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion
December 1, 2009
Study Registration Dates
First Submitted
November 24, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (Estimate)
November 25, 2008
Study Record Updates
Last Update Posted (Estimate)
March 11, 2011
Last Update Submitted That Met QC Criteria
March 8, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Insulin Resistance
- Hyperinsulinism
- Hypertension
- Metabolic Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
Other Study ID Numbers
- CSPP100A2410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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