Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients

NCT ID: NCT01048047

Last Updated: 2010-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

aliskiren/amlodipine

aliskiren, 300 mg/amlodipine 10 mg

Group Type EXPERIMENTAL

aliskiren/amlodipine

Intervention Type DRUG

aliskiren 300 mg /amlodipine 10 mg

amlodipine

amlodipine 10 mg

Group Type ACTIVE_COMPARATOR

aliskiren/amlodipine

Intervention Type DRUG

aliskiren 300 mg /amlodipine 10 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aliskiren/amlodipine

aliskiren 300 mg /amlodipine 10 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pavia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Pavia

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roberto Fogari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pavia

Pavia, , Italy

Site Status

University of Pavia

Pavia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT 2009

Identifier Type: REGISTRY

Identifier Source: secondary_id

UNIPV001DIM2009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.