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

July 19, 2009
May 16, 2011
June 2009
March 2010   (final data collection date for primary outcome measure)
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.
Change from baseline in Mean Seated Systolic Blood Pressure (MSSBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942994 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
412
Not Provided
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00942994
CSPA100AUS02
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP