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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00942994
First received: July 19, 2009
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Aliskiren/Amlodipine
Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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.


Enrollment: 412
Study Start Date: June 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

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

HCTZ capsule (12.5 mg, 25mg)

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.
Drug: Aliskiren/Amlodipine

Amlodipine capsule (5 mg)

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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942994

Locations
United States, Arkansas
K and S Research Services
Little Rock, Arkansas, United States, 72201
United States, Florida
Well Pharma Medical Research
South Miami, Florida, United States, 33143
United States, Massachusetts
Hyde Park Health Associates
Mattapan, Massachusetts, United States, 02126
United States, Virginia
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
United States, Washington
Scriber Kidney Center
Seattle, Washington, United States, 98133
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00942994     History of Changes
Other Study ID Numbers: CSPA100AUS02
Study First Received: July 19, 2009
Results First Received: March 29, 2011
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension
Aliskiren
Amlodipine
HCTZ
Systolic blood pressure
Diastolic blood pressure
Stage II
Combination

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents

ClinicalTrials.gov processed this record on July 29, 2014