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A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005290
First Posted: October 30, 2009
Last Update Posted: July 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferrer Internacional S.A.
  Purpose
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.

Condition Intervention Phase
Hypertension Drug: Combination pill Drug: Ramipril Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Interaction Study to Evaluate the Effect of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin and Ramipril (Cardiovascular Fixed Dose Combination Pill) on Blood Pressure

Resource links provided by NLM:


Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. [ Time Frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 ]
    Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.


Secondary Outcome Measures:
  • Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period [ Time Frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 ]
    Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period


Enrollment: 38
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination pill
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
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.
Active Comparator: Ramipril
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
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005290


Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, NY 10029-6574
Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
Principal Investigator: Valentin Fuster, MD, PhD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01005290     History of Changes
Other Study ID Numbers: P-080646-01
First Submitted: October 22, 2009
First Posted: October 30, 2009
Results First Submitted: March 30, 2012
Results First Posted: July 26, 2012
Last Update Posted: July 26, 2012
Last Verified: June 2012

Keywords provided by Ferrer Internacional S.A.:
cardiovascular
fixed
dose
combination
pill
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Ramipril
Aspirin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics