- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942994
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension (ASCENT)
May 16, 2011 updated by: Novartis
An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
412
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
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72201
- K and S Research Services
-
-
Florida
-
South Miami, Florida, United States, 33143
- Well Pharma Medical Research
-
-
Massachusetts
-
Mattapan, Massachusetts, United States, 02126
- Hyde Park Health Associates
-
-
Virginia
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Manassas, Virginia, United States, 20110
- Manassas Clinical Research Center
-
-
Washington
-
Seattle, Washington, United States, 98133
- Scriber Kidney Center
-
-
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 newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Men or women 18 years and older of minority background; self-identified.
- Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and <200 mmHg at Visit 5 (randomization).
Exclusion Criteria:
- Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any visit.
- Patients on 4 or more antihypertensive medications.
- Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1.
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: Triple Therapy (Aliskiren/Amlodipine/HCTZ)
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg.
At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5
mg.
At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg.
At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg) |
Active Comparator: Dual Therapy (Aliskiren/Amlodipine)
At week 0 patients were randomized to amlodipine 5 mg.
At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg.
At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg.
At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Time Frame: Baseline and week 8
|
To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
|
Baseline and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Time Frame: Baseline and week 8
|
To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
|
Baseline and week 8
|
Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
Time Frame: 8 weeks
|
To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Cumulative refers to achieving BP control before or at the corresponding visit.
|
8 weeks
|
Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
Time Frame: 8 weeks
|
To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Cumulative refers to achieving a response before or at the corresponding visit.
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Time Frame: Baseline, Week 2 and Week 4
|
Primary objective at additional timepoint.
|
Baseline, Week 2 and Week 4
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Time Frame: Baseline, Week 2 and Week 4
|
Secondary objective at additional timepoint.
|
Baseline, Week 2 and Week 4
|
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.
General Publications
- Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006.
- Ferdinand KC, Weitzman R, Purkayastha D, Sridharan K, Jaimes EA. Aliskiren-based dual- and triple-combination therapies in high-risk US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):219-27. doi: 10.1016/j.jash.2011.12.002. Epub 2012 Feb 3.
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
June 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
July 19, 2009
First Submitted That Met QC Criteria
July 20, 2009
First Posted (Estimate)
July 21, 2009
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
May 16, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
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
- CSPA100AUS02
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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