NCT01005290

Brief Summary

The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 26, 2012

Completed
Last Updated

July 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

October 22, 2009

Results QC Date

March 30, 2012

Last Update Submit

June 20, 2012

Conditions

Hypertension

Keywords

cardiovascularfixeddosecombinationpillhypertension

Outcome Measures

Primary Outcomes (1)

  • Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.

    Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.

    Days 7 and 36 of Period 1 and days 49 and 85 of Period 2

Secondary Outcomes (1)

  • Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period

    Days 7 and 36 of Period 1 and days 49 and 85 of Period 2

Study Arms (2)

Combination pill

EXPERIMENTAL

A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.

Drug: Combination pill

Ramipril

ACTIVE COMPARATOR

A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.

Drug: Ramipril

Interventions

Combination pillDRUG

A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.

Combination pill
RamiprilDRUG

A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.

Ramipril

Eligibility Criteria

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

You may qualify if:

  • Subjects will be ≥18 years old
  • Previously untreated systolic pressure result of ≥120\<160 mmHg and diastolic pressure result of ≥80\<100 mmHg

You may not qualify if:

  • Subjects must not have previously received any anti-hypertensive medication
  • must not have a systolic pressure \<120 mmHg or ≥160 mmHg and diastolic pressure result of \<80 mmHg or ≥100 mmHg
  • must not have had a previous coronary artery bypass graft (CABG)
  • must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent
  • must not have severe congestive heart failure (New York Heart Classification \[NYHC\] III-IV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, NY 10029-6574, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationRamipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CobicistatCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsTenofovirOrganophosphonatesOrganophosphorus CompoundsThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

Title
Natalia Oudovenko
Organization
Ferrer Internacional S.A.
noudovenko-research@ferrergrupo.com
+34 93 509 32 82

Study Officials

  • Valentin Fuster, MD, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 30, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 26, 2012

Results First Posted

July 26, 2012

Record last verified: 2012-06

Locations

US(1)