NCT01048047

Brief Summary

Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 13, 2010

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

January 12, 2010

Last Update Submit

January 12, 2010

Conditions

Hypertension

Keywords

aliskirenamlodipinehypertensionankle-foot volumemild and moderate hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure, heart rate, ankle-foot volume

    At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Secondary Outcomes (1)

  • Blood pressure and heart rate in sitting and standing position

    At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Study Arms (2)

aliskiren/amlodipine

EXPERIMENTAL

aliskiren, 300 mg/amlodipine 10 mg

Drug: aliskiren/amlodipine

amlodipine

ACTIVE COMPARATOR

amlodipine 10 mg

Drug: aliskiren/amlodipine

Interventions

aliskiren/amlodipineDRUG

aliskiren 300 mg /amlodipine 10 mg

aliskiren/amlodipineamlodipine

Eligibility Criteria

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

You may qualify if:

  • diastolic blood pressure \> 95 mmHg and \< 110 mmHg
  • systolic blood pressure \> 140 mmHg and \< 180 mmHg
  • no amlodipine therapy for the previous 6 months

You may not qualify if:

  • diastolic blood pressure \> 110 mmHg and or
  • systolic blood pressure \> 180 mmHg
  • secondary hypertension
  • heart failure
  • diabetes mellitus
  • liver or kidney diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pavia

Pavia, 27100, Italy

Location

University of Pavia

Pavia, Italy

Location

MeSH Terms

Conditions

HypertensionLymphoma, Follicular

Interventions

aliskirenAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Roberto Fogari, MD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

January 13, 2010

Record last verified: 2009-11

Locations

IT(2)