- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070030
Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension (ACADEMY)
Multi-center, Open Label, 18-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II HT
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand
- Investigative Site
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Chiang Mai, Thailand
- Investigative Site
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Nakhon Ratchasima, Thailand
- Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Outpatients 18 years of age or older
- Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicidal or an intrauterine device.
Patients with a diagnosis of hypertension as following msDBP & msSBP Requirements:
For newly diagnosed/untreated patients:
- Mean Sitting Diastolic Blood Pressure (msDBP) ≥ 100 and < 120 mmHg, and/or mean sitting Systolic Blood Pressure (msSBP) ≥ 160 and < 200 mmHg at Visit1.
For previously treated patients with 1 or 2 antihypertensive medications:
- msDBP ≥ 90 and < 100 mmHg, and/or msSBP ≥ 140 and < 160 mmHg at Visit 1 AND
- msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg at Visit 2.
For previously treated patients with Atenolol 50 mg once daily alone more than 2 weeks consecutively at visit 1:
- msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg.
- 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:
- Patients that previously participated in any Aliskiren study.
- Inability to receive or completely replace all previous antihypertensive medications with Atenolol 50 mg once daily for a period of 2 weeks as required by the protocol.
- Patients on 1 (other than Atenolol 50 mg once daily) or 2 antihypertensive drugs with msDBP ≥ 100 mmHg and/or msSBP ≥ 160 mmHg at Visit 1.
- Patients on 3 or more antihypertensive drugs at Visit 1.
- Pregnant or nursing (lactating) women, when pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (≥ 5 mIU/mL).
- Sexually active female patients who are not using effective contraceptive methods.
- Serum potassium <3.5 mEq/L (mmol/L) or > 5.5 mEq/L at Visit 1.
- Second or third degree heart block with or without a pacemaker, or other potentially life-threatening or symptomatic arrhythmia current or by history.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with stage II hypertension achieving blood pressure (BP) goal
Time Frame: 18 weeks
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The BP goal for non-diabetic patient is defined as msSBP < 140 mmHg and msDBP < 90 mmHg.
The BP goal for diabetic patient is msSBP < 130 mmHg and msDBP < 80 mmHg) in patients with stage II hypertension.
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18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants who have blood pressure surge to their baseline level during 24-h ambulatory blood pressure monitor (ABPM)
Time Frame: 18 weeks
|
24-h ABPM profiles were assessed by percentage of participants who have blood pressure (BP) surge to their baseline level (during 24-h ABPM) once after patients achieve BP goal (BP goal for non-diabetic patient is defined as msSBP < 140 mmHg and msDBP < 90 mmHg; and the BP goal for diabetic patient is msSBP < 130 mmHg and msDBP < 80) at any visit only in selected study sites.
The mean 24-hour MADBP (Mean Ambulatory Diastolic Blood Pressure) or MASBP (Mean Ambulatory Systolic Blood Pressure) is defined as the average of the hourly MADBP or MASBP over 24 hours respectively.
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18 weeks
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Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to study end
Time Frame: From baseline to study completion (between week 8 to 18)
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mSBP and mDBP is defined as an average of 2 points blood pressure measurements which 5 minutes apart.
Patient must be at rest for at least 5 minutes in sitting position before the heart rate and blood pressure measurement.
The arm for blood pressure measurement should be the same during the whole study.
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From baseline to study completion (between week 8 to 18)
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Number of participants with responder rate for Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Time Frame: 18 weeks
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The responder rate of msSBP is defined as msSBP < 140 mmHg for non-diabetic patients (msSBP < 130 mmHg for diabetic patients) or by a reduction of ≥ 20 mmHg BP from baseline. The responder rate of msDBP is defined as msDBP < 90 mmHg for non-diabetic patients ( msDBP < 80 mmHg for diabetic patients) or by a reduction of ≥ 10 mm Hg BP from baseline |
18 weeks
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Number of patients with any adverse events
Time Frame: 18 weeks
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An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the medicinal (investigational) product.
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18 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Sodium Chloride Symporter Inhibitors
- Amlodipine
- Hydrochlorothiazide
Other Study ID Numbers
- CSPP100ATH01
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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