Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
losartan hydrochlorothiazide · 4 trials · 2 indications
Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.
Plasma Area Under the Curve, a measure of drug exposure following dosing
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Drug Arm |
| 2 | ACTIVE_COMPARATOR | active comparator |
| losartan /HCTZ combination tablet | ACTIVE_COMPARATOR | single dose losartan 100 mg/HCTZ 12.5 mg combination tablet |
| losartan tablet + HCTZ capsule | ACTIVE_COMPARATOR | Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule |
| Name | Type | Description |
|---|---|---|
| losartan potassium (+) hydrochlorothiazide | DRUG | losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide |
| Comparator: Valsartan (+) Hydrochlorothiazide | DRUG | Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide |
| losartan potassium (+) hydrochlorothiazide (HCTZ) | DRUG | Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods. |
| losartan potassium | DRUG | Single dose losartan 100 mg tablet in one of two treatment periods. |
| hydrochlorothiazide (HCTZ) | DRUG | Single dose HCTZ 12.5 mg capsule in one of two treatment periods. |
Inclusion Criteria: * An Adult Patient 18 to 75 Years Of Age * Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled: * Either systolic...
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| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | QCZ484, HJB647 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | iloperidone |
| Opus Genetics, Inc. | IRD | 1 | PHASE1 | OPGx-BEST1 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX340 |
Losartan hydrochlorothiazide is used to treat hypertension. It combines losartan potassium, an angiotensin II receptor blocker, with hydrochlorothiazide, a thiazide diuretic, to lower blood pressure. The combination is studied in adults with essential hypertension, including patients whose blood pressure is not controlled on monotherapy.
Losartan hydrochlorothiazide targets AGTR1, the angiotensin II receptor type 1. Losartan acts as an antagonist at this receptor, blocking angiotensin II from raising blood pressure. Hydrochlorothiazide is a diuretic that increases sodium and water excretion. Together they lower blood pressure through complementary mechanisms.
Losartan hydrochlorothiazide is developed by Organon & Co., which trades under the ticker OGN. Organon is the company associated with the development of this fixed-dose combination product for hypertension.
Losartan hydrochlorothiazide has completed Phase 3 clinical development. Four trials are registered, all completed, with no active trials. The studies include Phase 1 bioequivalence work and Phase 3 hypertension trials. The drug is an investigational combination in the context of these registered studies.
Losartan hydrochlorothiazide has been studied in four completed trials: NCT00953680, a Phase 1 bioequivalence study; NCT00546754, a Phase 3 comparison with valsartan/HCTZ; NCT00546052, a 52 week Phase 3 metabolic study; and NCT00398541, a Phase 3 cognitive function study. Total enrollment across these trials was 2,664 participants.