Irbesartan and Amlodipine Combination in Controlling Blood Pressure

NCT00950066 | Completed Phase 2

• 1 other identifier: IRBES_R_04320
• Study Type: interventional
• Target: 270
• Locations: 4 countries
• Sites: 4

Brief Summary

The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo. The secondary objectives are:

• to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
• to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo

  At week 0, week 2, week 4 and week 8

Secondary Outcomes (2)

• Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo

  At week 0, week 2, week 4 and week 8

• Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo

  At week 0, week 2, week 4

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with placebo once a day.

Drug: Placebo

Irbesartan 150mg

ACTIVE COMPARATOR

Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg once a day.

Drug: IRBESARTAN (SR47436)

Irbesartan 150 mg / Amlodipine 5 mg

ACTIVE COMPARATOR

Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day.

Drug: Irbesartan / Amlodipine

Amlodipine

ACTIVE COMPARATOR

Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Amlodipine 5 mg once a day.

Drug: Amlodipine

Irbesartan 300 mg

ACTIVE COMPARATOR

Active Comparator: Irbesartan Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg once a day.

Drug: IRBESARTAN (SR47436)

Irbesartan 300 mg / Amlodipine 5 mg

ACTIVE COMPARATOR

Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day.

Drug: Irbesartan / Amlodipine

Interventions

IRBESARTAN (SR47436) DRUG

Oral administration of Irbesartan 150mg or 300mg once a day

Irbesartan 150mg; Irbesartan 300 mg

Amlodipine DRUG

Oral administration of Amlodipine 5mg once a day

Amlodipine

Irbesartan / Amlodipine DRUG

Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day

Irbesartan 150 mg / Amlodipine 5 mg; Irbesartan 300 mg / Amlodipine 5 mg

Placebo DRUG

Oral administration of a placebo once a day

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects with uncomplicated mild to moderate essential hypertension (as per European Society of Cardiology Classification of Hypertension)
• Treatment naïve subjects (newly diagnosed subjects or subjects currently only on lifestyle modification) with mean SeDBP of 95 to 109 mmHg at both screening and randomization visit (mean of 3 recordings at intervals of 1 minute) Or
• Uncontrolled on any anti-hypertensive monotherapy and with mean SeDBP of 90 to 109 mmHg at screening and mean SeDBP of 95 to 109 mmHg at the randomization visit (mean of 3 recordings at intervals of 1 minute).
• Subjects willing to adhere to protocol and study requirements during the entire study duration.
• Subjects having no abnormalities in general physical examination.

You may not qualify if:

• Subjects who are incapable of giving informed consent for the study.
• Subjects with SeDBP \> or = 110mmHg and / or SeSBP \> or = 180 mmHg measured at Doctor's office during screening or randomization visit
• Subjects having a difference of \> 8 mmHg between any 2 of the 3 SeDBP measurements either at screening or at randomization.
• Subjects who are on any anti-hypertensive therapy and unable to discontinue the anti-hypertensive therapy safely for a period of at least 2 weeks as required by the protocol.
• Subjects who cannot be discontinued on medications prohibited by the protocol.
• Subjects on combination therapies for treatment of hypertension.
• Subjects with known documented secondary hypertension including (but not limited to) hypertension secondary to coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
• Subjects with known diabetes (Type 1 or Type 2).
• Subjects with known documented complications of hypertension including (but not limited to):
• Cardiovascular disease: Ischemic heart disease (angina, myocardial infarction), heart failure, peripheral vascular disease.
• Cerebrovascular disease: Stroke, cerebral hemorrhage.
• Ophthalmic: Retinal hemorrhage, impaired vision, retinal microaneurysms.
• Subjects with known severe renal impairment (creatinine clearance \< 30 ml/min) calculated using the Cockcroft-Gault equation.
• Subjects with hyperkalemia (\>5.1mmol/L) and/or hyponatremia (\<133mmol/L).
• Subjects with known severe hepatic impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Sanofi-Aventis Administrative Office

Mumbai, India

Location

Sanofi-Aventis Administrative Office

Makati City, Philippines

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• Sanjay Aggarwal, MD

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 5, 2011

Record last verified: 2011-01

Locations

PH (1); IN (1); KR (1); TW (1)