NCT01638663

Brief Summary

The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure, pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide synthesis in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 cardiovascular-diseases

Timeline
Completed

Started May 2012

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, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

July 6, 2012

Last Update Submit

October 8, 2014

Conditions

Cardiovascular DiseasesNephropathy

Keywords

TolvaptanL-NMMAHealthy subjectsNephrologyCardiology

Outcome Measures

Primary Outcomes (1)

  • CH2O

    Measurement of H2O clearance at baseline, during and after L-NMMA infusion.

    5-6 Hours

Secondary Outcomes (6)

  • Urine biomarkers(Aquaporins, Epithelial Sodium Channels γ and β, Sodium/Chloride and Sodium/Potassium/Chloride cotransporter)

    5-6 Hours

  • Central blood pressure

    5-6 Hours

  • Pulse wave velocity

    5-6 Hours

  • Augmentation Index

    5-6 Hours

  • Vasoactive Hormones( Angiotensin II, Aldosterone, Endothelin, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Arginin Vasopressin)

    5-6 Hours

  • +1 more secondary outcomes

Study Arms (2)

Tolvaptan

ACTIVE COMPARATOR

Oral administration of 15 mg Tolvaptan on each examination day.

Drug: Tolvaptan

Placebo

PLACEBO COMPARATOR

Oral administration of 15 mg Unikalk tablet on each examination day.

Drug: Placebo

Interventions

TolvaptanDRUG

15 mg pr day for 1 day

Also known as: Samsca
Tolvaptan
PlaceboDRUG

1 tablet Unikalk 1 pr day for 1 day

Also known as: Unikalk
Placebo

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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safa Therwani

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Cardiovascular DiseasesKidney Diseases

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Safa Therwani, Bachelor

    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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, Dr.Sci.

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 12, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DK(1)