NCT00706134

Brief Summary

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
756

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3 hypertension

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

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 17, 2011

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

June 25, 2008

Results QC Date

January 10, 2011

Last Update Submit

June 24, 2011

Conditions

Hypertension

Keywords

Hypertension≥ 65 yearsaliskirenplacebolight meal

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)

    Baseline to end of study (Week 8)

Secondary Outcomes (5)

  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

    Baseline to end of study (Week 8)

  • Percentage of Patients Achieving Systolic Blood Pressure Response

    Baseline to end of study (Week 8)

  • Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study

    Baseline to end of study (Week 8)

  • Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)

    Baseline to end of study (Week 8)

  • Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)

    Baseline to end of study (week 8)

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Aliskiren 75 mg

EXPERIMENTAL
Drug: Aliskiren 75 mg

Aliskiren 150 mg

EXPERIMENTAL
Drug: Aliskiren 150 mg

Aliskiren 300 mg

EXPERIMENTAL
Drug: Aliskiren 300 mg

Interventions

PlaceboDRUG

Placebo tablet taken once daily in the morning with a light meal.

Placebo
Aliskiren 75 mgDRUG

Aliskiren 75 mg tablet taken once daily in the morning with a light meal.

Aliskiren 75 mg
Aliskiren 150 mgDRUG

Aliskiren 150 mg tablet taken once daily in the morning with a light meal.

Aliskiren 150 mg
Aliskiren 300 mgDRUG

Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Aliskiren 300 mg

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male and female outpatients 65 years of age and older.
  • Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
  • At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and \< 180 mmHg (msDBP \<110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

You may not qualify if:

  • Severe hypertension \[Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg\].
  • History or evidence of a secondary form of hypertension.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
  • Current diagnosis of heart failure (NYHA Class II-IV).
  • History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
  • Current angina pectoris requiring pharmacological therapy other than nitrates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Investigative Site

Buenos Aires, Argentina

Location

Investigative Site

Prague, Czechia

Location

Investigative Site

Berlin, Germany

Location

Investigative Site

Reykjavik, Iceland

Location

Investigative Site

Rome, Italy

Location

Investigative Site

Amsterdam, Netherlands

Location

Investigative Site

Warsaw, Poland

Location

Investigative Site

Bratislava, Slovakia

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 27, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 28, 2011

Results First Posted

June 17, 2011

Record last verified: 2011-06

Locations

CZ(1)DE(1)SL(1)NL(1)AR(1)PL(1)IC(1)IT(1)