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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00739596
First received: August 21, 2008
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.


Condition Intervention Phase
Hypertension
Drug: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks
Drug: Amlodipine: 8 weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An 8 Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.


Secondary Outcome Measures:
  • Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.

  • Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.

  • Percentage of Responders After 8 Weeks of Treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]

  • Percentage of Participants Achieving BP Control After 8 Weeks of Treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.


Enrollment: 332
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren Hydrochlorothiazide (HCTZ) Drug: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks
Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
Active Comparator: Amlodipine Drug: Amlodipine: 8 weeks
Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks

  Eligibility

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

Inclusion Criteria:

  • Patients 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 African American background; self identified
  • Patients with stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization)

Exclusion Criteria:

  • Office blood pressure measured by cuff (MSSBP ≥ 200 mmHg and/or MSDBP ≥ 110 mmHg) at any visit.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.
  • History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs.
  • Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.

    1. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
    2. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • History or evidence of a secondary form of hypertension.
  • Known Keith-Wagener Grade III or IV hypertensive retinopathy.
  • History of cerebrovascular accident, transient ischemic cerebral attack (TIA), heart failure (NYHA Class II-IV), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) in the last 12 months.
  • Current angina pectoris requiring pharmacological therapy.
  • Other protocol-defined inclusion/exclusion criteria may apply
  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: NCT00739596

Locations
United States, New Jersey
Sites in USA
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00739596     History of Changes
Other Study ID Numbers: CSPP100AUS03
Study First Received: August 21, 2008
Results First Received: December 14, 2010
Last Updated: February 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension
African American
aliskiren
hydrochlorothiazide
systolic blood pressure
diastolic blood pressure
amlodipine
stage 2

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 24, 2014