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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension

NCT00867490

Hypertension

COMPLETED PHASE3

Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans

NCT00739596

Hypertension

COMPLETED PHASE4

A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine

NCT00219154

Hypertension

COMPLETED PHASE3

Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

NCT00787605

Hypertension Diabetes Mellitus

COMPLETED PHASE4

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

NCT00705575

Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

Intervention Type DRUG

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

HCTZ capsule (12.5 mg, 25mg)

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.

Group Type ACTIVE_COMPARATOR

Aliskiren/Amlodipine

Intervention Type DRUG

Amlodipine capsule (5 mg)

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aliskiren/Amlodipine

Amlodipine capsule (5 mg)

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

Intervention Type DRUG

Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

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

HCTZ capsule (12.5 mg, 25mg)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No