Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension

NCT00942994 | Completed Phase 4 Results

• 1 other identifier: CSPA100AUS02
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Aliskiren; Amlodipine; HCTZ; Systolic blood pressure; Diastolic blood pressure; Stage II; Combination

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

  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.

  Baseline and week 8

Secondary Outcomes (3)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

  Baseline and week 8

• Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks

  8 weeks

• Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.

  8 weeks

Other Outcomes (2)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4

  Baseline, Week 2 and Week 4

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4

  Baseline, Week 2 and Week 4

Study Arms (2)

Triple Therapy (Aliskiren/Amlodipine/HCTZ)

EXPERIMENTAL

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.

Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

Dual Therapy (Aliskiren/Amlodipine)

ACTIVE COMPARATOR

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.

Drug: Aliskiren/Amlodipine

Interventions

Aliskiren/Amlodipine DRUG

Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)

Dual Therapy (Aliskiren/Amlodipine)

Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ) DRUG

Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg)

Triple Therapy (Aliskiren/Amlodipine/HCTZ)

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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (5)

K and S Research Services

Little Rock, Arkansas, 72201, United States

Location

Well Pharma Medical Research

South Miami, Florida, 33143, United States

Location

Hyde Park Health Associates

Mattapan, Massachusetts, 02126, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Scriber Kidney Center

Seattle, Washington, 98133, United States

Location

Related Publications (2)

• Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006.

  PMID: 21414565 RESULT

• Ferdinand KC, Weitzman R, Purkayastha D, Sridharan K, Jaimes EA. Aliskiren-based dual- and triple-combination therapies in high-risk US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):219-27. doi: 10.1016/j.jash.2011.12.002. Epub 2012 Feb 3.

  PMID: 22305998 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2009
• First Posted: July 21, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Last Updated: June 8, 2011
• Results First Posted: April 27, 2011

Record last verified: 2011-05

Locations

US (5)