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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ); Drug: Aliskiren/Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00942994

CSPA100AUS02

Details and patient eligibility

About

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.

Enrollment: 412 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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412 participants in 2 patient groups

Triple Therapy (Aliskiren/Amlodipine/HCTZ)

Experimental group

Description:

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.

Treatment:

Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

Dual Therapy (Aliskiren/Amlodipine)

Active Comparator group

Description:

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.

Treatment:

Drug: Aliskiren/Amlodipine