Use of Ramipril and Felodipine Combination Therapy in Hyp... | NCT00507845

Studies
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

NCT00507845

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 17, 2009Estimated

Enrollment

271Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Ramipril-Felodipine

Countries

Argentina

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

Apr 2009

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

Jun 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Jul 26, 2007

First Submission Date that Met QC Criteria

Jul 26, 2007

First Posted Date

Jul 27, 2007Estimated

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

Apr 16, 2009

Last Update Posted Date

Apr 17, 2009Estimated

Description Module

Brief Summary

Primary:

To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients

Secondary:

To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

271Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramipril-Felodipine	Drug	Ramipril + felodipine 2.5/2.5mg per tablet. One tablet to be taken Od for 8 weeks (this dose could be increased at week 2 to 4 to 5 mg daily because of uncontrolled hypertension).		Triacor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean changes in Systolic Blood Pressure (SBP)		from baseline to Week 8

Secondary Outcomes

Measure	Description	Time Frame
Mean changes in Diastolic Blood Pressure (DBP)		from baseline to Week 8
Percentage of responders with regard to DBP and SBP		comparison to baseline
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient
Patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ACE inhibitors, AT2 blockers)(uncontrolled hypertension).

Exclusion Criteria:

Already on fixed-dose combination treatment for hypertension
Contraindication to angiotensin converting enzyme (ACE) inhibitors or CCB therapy
Known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ACE or any of the excipients of ramipril felodipine.
History of angioedema
Unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
Patients with AV block II or III
Severely impaired hepatic function.
Pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
Pregnant and lactating mothers
Patients on dialysis or haemofiltration.
Patients with creatinine clearance < 20ml/min
Use of potassium sparing diuretics
Severe hypertension (SBP ≥ 180 mmhg or DBP ≥ 110 mmhg)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases