Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension (ASCENT)

Tracking Information
First Submitted Date ICMJE	July 19, 2009
First Posted Date ICMJE	July 21, 2009
Results First Submitted Date	March 29, 2011
Results First Posted Date	April 27, 2011
Last Update Posted Date	June 8, 2011
Study Start Date ICMJE	June 2009
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 16, 2011)	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.
Original Primary Outcome Measures ICMJE; (submitted: July 20, 2009)	Change from baseline in Mean Seated Systolic Blood Pressure (MSSBP) [ Time Frame: 8 weeks ]
Change History	Complete list of historical versions of study NCT00942994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 16, 2011)	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.; 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.; 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.
Original Secondary Outcome Measures ICMJE; (submitted: July 20, 2009)	Change from baseline in MSDBP [ Time Frame: 8 weeks ]; Percentage of patients achieving blood pressure (BP) control (defined as MSSBP < 140 mmHg and MSDBP < 90) [ Time Frame: 8 weeks ]; Percentage of responders (defined as patients with MSSBP < 140 mmHg or a reduction from baseline in US MSSBP of > 20 mmHg) [ Time Frame: 8 weeks ]; Change in MSSBP in patients with baseline MSSBP ≥ 180 mmHg and < 200 mmHg and Type 2 diabetes mellitus [ Time Frame: 8 weeks ]; Safety and tolerability of aliskiren, amlodipine and HCTZ treatment versus an aliskiren and amlodipine treatment in minority patients with Stage 2 hypertension [ Time Frame: 8 weeks ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Hypertension
Intervention ICMJE	Drug: Aliskiren/Amlodipine Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg); Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg)
Study Arms	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. Intervention: Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ); 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. Intervention: Drug: Aliskiren/Amlodipine
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 29, 2011)	412
Original Estimated Enrollment ICMJE; (submitted: July 20, 2009)	402
Study Completion Date	Not Provided
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00942994
Other Study ID Numbers ICMJE	CSPA100AUS02
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	External Affairs, Novartis Pharmaceuticals
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Novartis
PRS Account	Novartis
Verification Date	May 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP