Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

NCT01277822 | Completed Phase 4 Results

• 1 other identifier: 0954F-399
• Study Type: interventional
• Target: 334
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Conditions

Hypertension

Keywords

Hypertension; Uncontrolled hypertension; High blood pressure; Uncontrolled high blood pressure; Untreated high blood pressure; Untreated hypertension; Essential hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

  Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.

  Baseline and Week 8

Secondary Outcomes (7)

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4

  Baseline and Week 4

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

  Baseline and Week 8

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4

  Baseline and Week 4

• Percentage of Participants Who Achieve Target Blood Pressure at Week 8

  Week 8

• Percentage of Participants Who Achieve Target Blood Pressure at Week 4

  Week 4

Study Arms (2)

Losartan/amlodipine Treatment Arm

EXPERIMENTAL

One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.

Drug: Losartan (+) amlodipine; Drug: Placebo to match amlodipine

Amlodipine Treatment Arm

ACTIVE COMPARATOR

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.

Drug: Placebo to match losartan/amlodipine tablets; Drug: Amlodipine camsylate

Interventions

Losartan (+) amlodipine DRUG

One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.

Also known as: COZAAR XQ™

Losartan/amlodipine Treatment Arm

Placebo to match losartan/amlodipine tablets DRUG

One tablet containing placebo, orally, once daily, for 8 weeks.

Amlodipine Treatment Arm

Amlodipine camsylate DRUG

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.

Amlodipine Treatment Arm

Placebo to match amlodipine DRUG

2 tablets containing placebo, orally, once daily, for 8 weeks.

Losartan/amlodipine Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with essential hypertension:
• who are on single drug therapy
• who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
• who have blood pressure readings of 90mmHg ≤ MSDBP \< 110mmHg and 140mmHg ≤ MSSBP \<180mmHg after 2 weeks wash-out for patients on single agent.
• Randomization (Visit 3)
• After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:
• mmHg ≤ MSDBP \< 110mmHg and 140mmHg ≤ MSSBP \< 180mmHg.

You may not qualify if:

• Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
• Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
• Participant with known secondary hypertension of any etiology.
• Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
• Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.
• Participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

amlodipine-losartan drug combination; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: May 30, 2011
• Primary Completion: April 22, 2013
• Study Completion: April 22, 2013
• Last Updated: June 20, 2024
• Results First Posted: April 24, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share