Placebo Effects on Blood Pressure Induced by Expectancy M... | NCT00937196

Studies
Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

NCT00937196

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Aug 13, 2013Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Blood Pressure

Interventions

Placebo globuli
Histaminum hydrochloricum globuli

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Jul 9, 2009

First Posted Date

Jul 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2013

Last Update Posted Date

Aug 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karin Meissner, PD Dr. med., Ludwig-Maximilians - University of MunichPrincipal Investigator

Lead Sponsor

Ludwig-Maximilians - University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the present study was to examine the effects of a single placebo intervention on blood pressure and to investigate autonomic and psychological mediating mechanisms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Histaminum hydrochloricum globuli	Active Comparator	To allow double-blind administration of the placebo pills going along with verbal suggestions of a blood-pressure-lowering effect	Drug: Histaminum hydrochloricum globuli
Placebo globuli	Experimental		Drug: Placebo globuli
No treatment	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo globuli	Drug	placebo globuli administered together with verbal suggestions of a hypotensive drug effect	Placebo globuli

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure (systolic, diastolic)		minutes 1 to 30 after intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent

Exclusion Criteria:

not meeting inclusion criteria
hypotension or hypertension
treated or untreated hypertension or hypotension
Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
diseases that influence the cardiovascular or gastrointestinal system
intake of drugs affecting blood pressure and/or autonomic nervous system
pregnancy and lactation phase
body mass index >= 32
cardiovascular risk factors (diabetes, smoking)
drug or alcohol abuse
insufficient compliance
participation in another trial within the last three months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karin Meissner, MD	Ludwig-Maximilians - University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Medical Psychology, Ludwig-Maximilians-University Munich		Munich		80336	Germany