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Blood Pressure Lowering of Aliskiren HCTZ Versus Amlodipine in Stage 2 Hypertension in African Americans (ATLAAST)
This study is currently recruiting participants.
Verified by Novartis, August 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00739596
  Purpose

The purpose of the study is to evaluate the efficacy and safety of initial use 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:
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in MSSBP after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in MSDBP after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in mean sitting pulse pressure after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of responders after 8 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving BP control after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of aliskiren HCTZ versus Amlodipine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: July 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks Aliskiren HCTZ 150/12.5 mg: 1 week ALiskiren HCTZ 300/25 mg: 7 weeks
Drug: Aliskiren Hydrochlorothiazide(HCTZ): 8 weeks
Aliskiren HCTZ 150/12.5 mg: 1 week Aliskiren HCTZ 300/25 mg: 7 weeks
2: Active Comparator
Amlodipine 5 mg: 1 week Amlodipine 10 mg: 7 weeks
Drug: Amlodipine:
Amlodipine 5 mg: 1 week Amlodipine 10 mg: 7 weeks

  Eligibility

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

Inclusion Criteria:

  1. Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
  2. Men or women 18 years and older of African American background; self identified
  3. Patients with stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization)

Exclusion Criteria:

  1. Office blood pressure measured by cuff (MSSBP ≥ 200 mmHg and/or MSDBP ≥ 110 mmHg) at any visit.
  2. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.
  3. 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.
  4. Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
  5. 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.
  6. 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)
  7. 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.
  8. History or evidence of a secondary form of hypertension.
  9. Known Keith-Wagener Grade III or IV hypertensive retinopathy.
  10. 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.
  11. Current angina pectoris requiring pharmacological therapy. Other protocol-defined inclusion/exclusion criteria may apply -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739596

Contacts
Contact: Novartis 862-778-8300

Locations
United States, Virginia
Investigative Site Recruiting
Richmond, Virginia, United States
Contact: Novartis     862-778-8300        
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CSPP100AUS03
Study First Received: August 21, 2008
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00739596  
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

Study placed in the following topic categories:
Calcium, Dietary
Vascular Diseases
Hydrochlorothiazide
Amlodipine
Hypertension

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

ClinicalTrials.gov processed this record on January 16, 2009