NCT01214746

Brief Summary

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2 cardiovascular-diseases

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2 cardiovascular-diseases

Geographic Reach
1 country

1 active site

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, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

1.1 years

First QC Date

May 18, 2010

Last Update Submit

August 15, 2011

Conditions

Cardiovascular DiseasesNephropathy

Keywords

StatinL-NMMAHealthy subjectsNephrology

Outcome Measures

Primary Outcomes (1)

  • Fractional excretion of sodium

    Sodium excretion measured before, during and after L-NMMA infusion

    5 days treatment

Secondary Outcomes (11)

  • Systolic blood pressure (SBP)

    5 days

  • Pulse wave velocity

    5 days

  • plasma renin concentration

    5 days

  • Augmentation index (AI)

    5 days

  • Diastolic blood pressure

    5 days

  • +6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Atorvastatin

ACTIVE COMPARATOR
Drug: Atorvastatin

Interventions

PlaceboDRUG

1 tablet Unikalk 1 time pr day for 5 days

Also known as: Unikalk
Placebo
AtorvastatinDRUG

Zarator, 80 mg pr day for 5 days

Also known as: Zarator
Atorvastatin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, age 18-40 years
  • Body Mass Index (BMI) 18,5-30 kg/m2

You may not qualify if:

  • Arterial hypertension (\>140 mmHg systolic and/or 90 mmHg diastolic)
  • Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
  • Neoplastic disease
  • Alcohol abuse,
  • Drug abuse
  • Medical treatment except oral anticontraceptive
  • Smoking
  • Pregnancy or
  • Abnormal blood and urine sample
  • Abnormal ECG
  • Blood donation within a month before examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicinsk Forskning, Regionshospitalet Holstebro

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Cardiovascular DiseasesKidney Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Frank H Christensen, MD

    Medicinsk Forskning

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2010

First Posted

October 5, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

DK(1)