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

NCT00739596 | Completed Phase 4 Results

• 1 other identifier: CSPP100AUS03
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; African American; aliskiren; hydrochlorothiazide; systolic blood pressure; diastolic blood pressure; amlodipine; stage 2

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment

  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.

  Baseline and 8 weeks

Secondary Outcomes (4)

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment

  Baseline and 8 weeks

• Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment

  Baseline and 8 weeks

• Percentage of Responders After 8 Weeks of Treatment.

  8 weeks

• Percentage of Participants Achieving BP Control After 8 Weeks of Treatment

  8 weeks

Study Arms (2)

Aliskiren Hydrochlorothiazide (HCTZ)

EXPERIMENTAL

Drug: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks

Amlodipine

ACTIVE COMPARATOR

Drug: Amlodipine: 8 weeks

Interventions

Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks DRUG

Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks

Aliskiren Hydrochlorothiazide (HCTZ)

Amlodipine: 8 weeks DRUG

Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks

Amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Sites in USA

East Hanover, New Jersey, United States

Location

Related Publications (1)

• Ferdinand KC, Pool J, Weitzman R, Purkayastha D, Townsend R. Peripheral and central blood pressure responses of combination aliskiren/hydrochlorothiazide and amlodipine monotherapy in African American patients with stage 2 hypertension: the ATLAAST trial. J Clin Hypertens (Greenwich). 2011 May;13(5):366-75. doi: 10.1111/j.1751-7176.2010.00416.x. Epub 2011 Jan 18.

  PMID: 21545398 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 27, 2016
• Results First Posted: January 12, 2011

Record last verified: 2011-02

Locations

US (1)