Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

NCT00765947 | Completed Phase 4 Results

• 1 other identifier: CSPP100A2360
• Study Type: interventional
• Target: 256
• Locations: 4 countries
• Sites: 4

Brief Summary

This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).

Conditions

Essential Hypertension ( Mild to Moderate)

Keywords

Essential Hypertension ( mild to moderate)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen

  For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure \[msSBP\] \< 140 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure \[msSBP\] \< 130 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 80 mmHg.

  24 weeks

Secondary Outcomes (3)

• Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.

  24 weeks

• Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]

  Baseline and Week 24

• Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]

  24 weeks

Study Arms (1)

Aliskiren-based regimen

EXPERIMENTAL

All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.

Drug: Aliskiren; Drug: Hydrochlorothiazide; Drug: Amlodipine

Interventions

Aliskiren DRUG

Aliskiren 150 or 300 mg

Aliskiren-based regimen

Hydrochlorothiazide DRUG

Hydrochlorothiazide 12.5 or 25 mg

Aliskiren-based regimen

Amlodipine DRUG

Amlodipine 5 or 10 mg

Aliskiren-based regimen

Eligibility Criteria

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

You may qualify if:

• Outpatients ≥ 18 years of age
• Patients with a diagnosis of mild to moderate hypertension at Visit 1
• All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3

You may not qualify if:

• Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg
• Secondary form of hypertension
• Current diagnosis of heart failure (NYHA Class II-IV)
• Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
• Second or third degree heart block without a pacemaker
• Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1

Sponsors & Collaborators

• Novartis: lead

Study Sites (4)

Investigative Site

Paris, France

Location

Investigative Site

Budapest, Hungary

Location

Investigative Site

Bucharest, Romania

Location

Investigative Site

Bratislava, Slovakia

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

aliskiren; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Hypertension; 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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 6, 2020
• Results First Posted: January 11, 2011

Record last verified: 2020-07

Locations

HU (1); SL (1); FR (1); RO (1)