A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population

NCT00930722 | Completed Results

• 1 other identifier: A9061066
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 18

Brief Summary

This is a prospective, non-interventional, non comparative drug study. The efficacy of Quinapril in Asian population has been evaluated, but specifically in Indian patients the data is sparse. Data in a real world setting in a large population of Indian patients would shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian population.

Conditions

Hypertension

Keywords

Quinapril non-interventional/observational study safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Baseline to Week 52

Secondary Outcomes (11)

• Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

  Baseline and Week 12

• Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12

  Baseline and Week 12

• Change From Baseline in SBP at Week 52

  Baseline and Week 52

• Change From Baseline in DBP at Week 52

  Baseline and Week 52

• Change From Pre-treatment in SBP at Week 0

  Pre-treatment and Week 0

Study Arms (1)

quinapril

quinapril

Drug: quinapril

Interventions

quinapril DRUG

per label as non interventional study

Also known as: Acupil®

quinapril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400 patients will be included in this non-interventional study. Only hypertensive subjects, over the age of 18 years, and who have already been receiving Acupil® for a minimum duration of 4 weeks will be included in the study.

You may qualify if:

• Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document

You may not qualify if:

• Patients having a Week 0 visit blood pressure reading of more than 180/110 mm of Hg will not be eligible to participate in the study.
• Women of child bearing age, not willing to use contraceptives, will not be eligible for the study
• Women using oral contraceptives will also not be included in the study
• Patients who have received any drug other than Acupil® as the first prescribed antihypertensive would not be eligible for enrollment into the trial
• Patients having any complication at Week 0 visit which would require more thorough investigations or who required more than one anti-hypertensive drug at the time of initiation of their therapy will not be included in the study
• Patients having any contraindications as per the LPD of Acupil®

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Pfizer Investigational Site

Patna, Bihar, 01, India

Location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 015, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 003, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 051, India

Location

Pfizer Investigational Site

Ahmedabad, Maharashtra, 380 015, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440 015, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440 033, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411 004, India

Location

Pfizer Investigational Site

Delhi, New Delhi, 110017, India

Location

Pfizer Investigational Site

Jaipur, Rajasthan, 302 020, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 600 035, India

Location

Pfizer Investigational Site

Madurai, Tamil Nadu, 625 010, India

Location

Pfizer Investigational Site

Madurai, Tamil Nadu, 625 107, India

Location

Pfizer Investigational Site

Madurai, Tamil Nadu, 625003, India

Location

Pfizer Investigational Site

Madurai, Tamil Nadu, 625014, India

Location

Pfizer Investigational Site

Trichy, Tamil Nadu, 620 021, India

Location

Pfizer Investigational Site

Kanpur, Uttar Pradesh, 208005, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 20, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension

Interventions

Quinapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 4, 2011
• Results First Posted: May 4, 2011

Record last verified: 2011-04

Locations

IN (18)