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Completed

NCT Number: NCT00942994

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

K and S Research Services, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aliskiren/Amlodipine

Drug

Amlodipine capsule (5 mg)

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

Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

Drug

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

HCTZ capsule (12.5 mg, 25mg)

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4

    Time frame: Baseline, Week 2 and Week 4

    Primary objective at additional timepoint.

  2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4

    Time frame: Baseline, Week 2 and Week 4

    Secondary objective at additional timepoint.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Acronym: ASCENT

Important dates

Study start
2009
Primary completion
2010
First posted
Jul 21, 2009
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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