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

Novartis412 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

412

Conditions

Hypertension

Interventions

Aliskiren/AmlodipineDRUG

Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)

Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)DRUG

Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

K and S Research Services

Little Rock, Arkansas, United States

Well Pharma Medical Research

South Miami, Florida, United States

Hyde Park Health Associates

Mattapan, Massachusetts, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Outcomes

Primary Outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at 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.

Time frame: Baseline and week 8

Secondary Outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at 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.

Time frame: Baseline and week 8

Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 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.

Time frame: 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.

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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