A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

NCT01307033 | Completed Phase 3 Results

• 1 other identifier: 0954A-351
• Study Type: interventional
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Conditions

Hypertension

Keywords

Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)

  Up to 52 weeks

Secondary Outcomes (2)

• Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8

  Baseline and Week 8 (End of Double-blind Period)

• Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8

  Baseline and Week 8 (End of Double-blind Period)

Study Arms (2)

MK-954H (L50/H12.5)

ACTIVE COMPARATOR

One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)

Drug: MK-954H; Drug: Placebo to MK-0954A

MK-0954A (L100/H12.5)

EXPERIMENTAL

One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension

Drug: MK-0954A; Drug: Placebo to MK-954H

Interventions

MK-0954A DRUG

Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily

MK-0954A (L100/H12.5)

MK-954H DRUG

Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily

Also known as: Preminent®

MK-954H (L50/H12.5)

Placebo to MK-0954A DRUG

Placebo tablet to match MK-0954A, once daily

MK-954H (L50/H12.5)

Placebo to MK-954H DRUG

Placebo tablet to match MK-954H, once daily

MK-0954A (L100/H12.5)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a diagnosis of essential hypertension.
• Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
• Participant has a mean trough SiDBP of \>=90mmHg and \< 110mmHg.
• Participant has a mean trough SiSBP of \>=140mmHg and \< 200mmHg.
• Participant has no clinically significant abnormality at screening visit.

You may not qualify if:

• Participant is currently taking \> 2 antihypertensive medications.
• Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).
• Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.
• Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.
• Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3.

  PMID: 24990091 RESULT

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

hydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: March 29, 2011
• Primary Completion: December 4, 2012
• Study Completion: December 4, 2012
• Last Updated: May 17, 2024
• Results First Posted: January 6, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share