NCT00841880

Brief Summary

The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg. To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP\<140mmHg and/or DBP\<90mmHg) and as SBP \< 130 mmHg and /or DBP \< 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score \> 10%. To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population. To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4 hypertension

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

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 27, 2010

Status Verified

August 1, 2010

Enrollment Period

8 months

First QC Date

February 10, 2009

Last Update Submit

August 26, 2010

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Seated SBP at office

    After 8-week treatment

Secondary Outcomes (4)

  • Seated DBP at office

    After 4 and 8-week treatment

  • Seated SBP at office

    After 4-week treatment

  • Response rate

    After 4 and 8-week treatment

  • BP controlled rate

    After 4 and 8-week treatment

Study Arms (2)

1

EXPERIMENTAL

2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine

Drug: Ramipril + FelodipineDrug: Ramipril

2

ACTIVE COMPARATOR

2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg

Drug: Ramipril

Interventions

Ramipril + FelodipineDRUG

Ramipril 5mg + Felodipine 5mg once a day

1
RamiprilDRUG

10 mg once a day

2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled essential hypertension defined by office SBP/DBP \> 140/90 or \> 130/80 mmHg for compelling indications (diabetes mellitus, chronic kidney disease, known CAD or CAD equivalent or 10-year Framingham risk score \> 10%)
  • Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks

You may not qualify if:

  • Female who are pregnant or breast feeding
  • Office DBP\> 110mmHg or office SBP \>180mmHg
  • Hypersensitivity to ramipril, felodipine or to any of the excipients
  • Bilateral stenosis of the renal arteries, or unilateral stenosis in the single kidney
  • History of intolerance to any ACE inhibitor
  • History of significant renal diseases including: serum creatinine \>3.0 mg/dl, or creatinine clearance \<30 ml/min
  • History of hereditary and/or idiopathic angioedema; or angioedema associated with previous ACEI
  • Significant cardiovascular diseases, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
  • Hepatic disease as indicated by any of the following: Serum Glutamooxaloacetate Transferase (SGOT) or Serum Glutamopyruvate Transferase (SGPT)\>3 x upper limit of normal, or serum bilirubin \> 2 x upper limit of normal
  • Any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objective.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

RamiprilFelodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Fern Lim

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 27, 2010

Record last verified: 2010-08

Locations

TW(1)