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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ); Drug: Aliskiren/Amlodipine

• Registration Number: NCT00942994
• Lead Sponsor: Novartis

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 available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-19
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Primary Completion: 2010-03
• Results First Submitted: 2011-03-29
• Results First Submitted QC: 2011-03-29
• Results First Posted: 2011-04-27
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple Therapy (Aliskiren/Amlodipine/HCTZ)	Aliskiren/Amlodipine and Hydrochlorothiazide (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.
Dual Therapy (Aliskiren/Amlodipine)	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8	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	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.	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.

Trial Locations

Locations (5)

K and S Research Services; 🇺🇸 Little Rock, Arkansas, United States

Scriber Kidney Center; 🇺🇸 Seattle, Washington, 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