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

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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.

• Change from baseline in MSDBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Percentage of patients achieving blood pressure (BP) control (defined as MSSBP < 140 mmHg and MSDBP < 90) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Change in MSSBP in patients with baseline MSSBP ≥ 180 mmHg and < 200 mmHg and Type 2 diabetes mellitus [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]

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.

• 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)

• 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

• 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.

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.