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

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2010

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • External Affairs, Novartis Pharmaceuticals
  • Overall Official(s)
    • Novartis, Study Director, Novartis

Citations Reporting on Results

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.