Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks (Drug); Amlodipine: 8 weeks (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis, Study Director, Affiliation: Novartis
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment
Secondary outcome: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of TreatmentChange in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment Percentage of Responders After 8 Weeks of Treatment. Percentage of Participants Achieving BP Control After 8 Weeks of Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sites in USA, East Hanover, New Jersey, United States
Additional Information
Starting date: July 2008
Last updated: February 14, 2011
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