NCT00627952

Brief Summary

Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

February 24, 2008

Last Update Submit

January 18, 2013

Conditions

Hypertension

Keywords

hypertensionintraglomerular pressure

Outcome Measures

Primary Outcomes (1)

  • effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure

    4 weeks

Secondary Outcomes (1)

  • effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure

    4 weeks

Study Arms (2)

amlodipine 10 mg

ACTIVE COMPARATOR
Drug: amlodipine 10 mgDrug: amlodipine 5 mg + delapril 30 mg

manidipine 20 mg

ACTIVE COMPARATOR
Drug: manidipine 20 mgDrug: manidipine 10 mg + delapril 30 mg

Interventions

amlodipine 10 mgDRUG

amlodipine 10 mg once daily

amlodipine 10 mg
manidipine 20 mgDRUG

manidipine 20 mg once daily

manidipine 20 mg
amlodipine 5 mg + delapril 30 mgDRUG

amlodipine 5 mg + delapril 30 mg once daily

amlodipine 10 mg
manidipine 10 mg + delapril 30 mgDRUG

manidipine 10 mg + delapril 30 mg once daily

manidipine 20 mg

Eligibility Criteria

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

You may qualify if:

  • male or female patients aged 18 years or older
  • mild to moderate hypertension (systolic blood pressure \> 139 mmHg or diastolic blood pressure \> 89 mmHg)

You may not qualify if:

  • secondary form of arterial hypertension
  • severe hypertension (systolic blood pressure \> 179 mmHg or diastolic blood pressure \> 109 mmHg)
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

  • Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.

    PMID: 29268712DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipinemanidipinedelapril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Roland E Schmieder, Professor

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 4, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DE(1)