A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension

NCT00649311 | Terminated Phase 2

• 2 other identifiers: EPLA-0501-072A6141012
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8

  8 weeks

Secondary Outcomes (3)

• Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8

  8 weeks

• Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP

  8 weeks

• Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events

  8 weeks

Study Arms (2)

Eplerenone group

EXPERIMENTAL

Drug: eplerenone

Losartan group

ACTIVE COMPARATOR

Drug: Losartan

Interventions

eplerenone DRUG

Eplerenone 50 mg oral film-coated tablet once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to eplerenone 100 mg oral film-coated tablet once daily for 4 weeks.

Eplerenone group

Losartan DRUG

Losartan 50 mg oral capsule once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to losartan 100 mg oral capsule once daily for 4 weeks

Losartan group

Eligibility Criteria

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

You may qualify if:

• History of mild to moderate hypertension, or newly diagnosed hypertension, defined as seDBP ≥90 mmHg and \<110 mmHg and seSBP \<180 mmHg
• Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period

You may not qualify if:

• Secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, Cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension
• The patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ACE-I, ARB, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Kaohsiung City, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Hypertension

Interventions

Eplerenone; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: April 1, 2003
• Study Completion: September 1, 2003
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

TW (2)