Clinical trial NCT00942994: Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Aliskiren
Amlodipine
HCTZ
Systolic blood pressure
Diastolic blood pressure
Stage II
Combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-07-21
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
timeFrame: Baseline and week 8
measure: Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
timeFrame: 8 weeks
Other outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
timeFrame: Baseline, Week 2 and Week 4
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
timeFrame: Baseline, Week 2 and Week 4
Locations:
city: Little Rock
country: United States
facility: K and S Research Services
state: Arkansas
city: South Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Mattapan
country: United States
facility: Hyde Park Health Associates
state: Massachusetts
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: Scriber Kidney Center
state: Washington
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.