Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension

NCT01289132 | Completed Phase 2

• 2 other identifiers: TAK-536/CCT-001U1111-1118-3346
• Study Type: interventional
• Target: 926
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.

Conditions

Essential Hypertension

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).

  The change between sitting trough clinic diastolic blood pressure measured at week 12 or final visit from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.

  Baseline and Week 12.

Secondary Outcomes (25)

• Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).

  Baseline and Week 2.

• Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).

  Baseline and Week 4.

• Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).

  Baseline and Week 6.

• Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).

  Baseline and Week 8.

• Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).

  Baseline and Week 10.

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Azilsartan 5 mg QD

EXPERIMENTAL

Drug: Azilsartan

Azilsartan 10 mg QD

EXPERIMENTAL

Drug: Azilsartan

Azilsartan 20 mg QD

EXPERIMENTAL

Drug: Azilsartan

Azilsartan 40 mg QD

EXPERIMENTAL

Drug: Azilsartan

Azilsartan 80 mg QD

EXPERIMENTAL

Drug: Azilsartan

Candesartan Cilexetil 8 mg titrated to12 mg QD

ACTIVE COMPARATOR

Drug: Candesartan cilexetil

Interventions

Placebo DRUG

Placebo-matching tablets, orally, once daily for up to 12 weeks.

Placebo

Azilsartan DRUG

Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.

Also known as: TAK-536

Azilsartan 5 mg QD

Candesartan cilexetil DRUG

Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.

Also known as: Blopress®, TCV-116

Candesartan Cilexetil 8 mg titrated to12 mg QD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has mild to moderate uncomplicated essential hypertension.
• Has a sitting diastolic blood pressure between 95 and \<110 mmHg and sitting systolic blood pressure between 150 and \<180 mmHg at placebo run-in period (Week -2) or randomization visit.

You may not qualify if:

• Has a cardiovascular disease or symptoms
• Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.
• Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Essential Hypertension

Interventions

azilsartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Professor Geriatric Medicine and Nephrology

  Osaka University Graduate School of Medicine

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 3, 2011

Record last verified: 2011-02