NCT00402103

Brief Summary

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Nov 2006

Geographic Reach
8 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 11, 2011

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

1.4 years

First QC Date

November 18, 2006

Results QC Date

December 13, 2010

Last Update Submit

March 8, 2011

Conditions

Hypertension

Keywords

Hypertension, aliskiren, amlodipine, HCTZ, blood pressure

Outcome Measures

Primary Outcomes (1)

  • Overall Percentage of Patients With Adverse Events

    52 weeks

Secondary Outcomes (3)

  • Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points

    Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54

  • Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg

    Baseline, Week 2, Week 10, Week 28 and Week 54

  • Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)

    Baseline, Week 2, Week 10, Week 28 and Week 54

Study Arms (2)

Aliskiren/Amlodipine

EXPERIMENTAL
Drug: AliskirenDrug: Amlodipine

Aliskiren/Amlodipine/HCTZ

EXPERIMENTAL
Drug: AliskirenDrug: AmlodipineDrug: Hydrochlorothiazide

Interventions

AliskirenDRUG

All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

Aliskiren/AmlodipineAliskiren/Amlodipine/HCTZ
AmlodipineDRUG

All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

Aliskiren/AmlodipineAliskiren/Amlodipine/HCTZ
HydrochlorothiazideDRUG

Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Aliskiren/Amlodipine/HCTZ

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients 18 years of age or older
  • Male or female patients are eligible
  • For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
  • For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)

You may not qualify if:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Investigative Site

Santa Fe, New Mexico, United States

Location

Investigator Site

Investigative Site, Belgium

Location

Investigative Center

Investigative Center, Denmark

Location

Investigative Site

Investigative Site, Finland

Location

Investigative Center

Investigative Center, Germany

Location

Investigative Site

Investigative Site, Iceland

Location

Investigative Site

Investigative Site, India

Location

Investigative Site

Investigative Site, Switzerland

Location

Related Publications (1)

  • Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.

    PMID: 19257800DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskirenAmlodipineHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2006

First Posted

November 22, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 10, 2011

Results First Posted

January 11, 2011

Record last verified: 2011-03

Locations

US(1)IC(1)DK(1)FI(1)BE(1)CH(1)DE(1)IN(1)