CLINICAL TRIALS PROFILE FOR LOPRESSOR HCT

All Clinical Trials for LOPRESSOR HCT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00123604 ↗	Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes	Completed	GlaxoSmithKline	Phase 4	2004-06-01	The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
NCT00123604 ↗	Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes	Completed	St. Paul Heart Clinic	Phase 4	2004-06-01	The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.

Clinical Trial Conditions for LOPRESSOR HCT

Condition Name

Condition Name for LOPRESSOR HCT
Intervention	Trials
Hypertension	11
Healthy	6
Atrial Fibrillation	5

Condition MeSH

Condition MeSH for LOPRESSOR HCT
Intervention	Trials
Hypertension	10
Atrial Fibrillation	5
Pure Autonomic Failure	2

Clinical Trial Locations for LOPRESSOR HCT

Trials by Country

Trials by Country for LOPRESSOR HCT
Location	Trials
United States	31
Canada	4
France	1

Trials by US State

Trials by US State for LOPRESSOR HCT
Location	Trials
Minnesota	4
West Virginia	3
Florida	3
Tennessee	3
Nebraska	2

Clinical Trial Progress for LOPRESSOR HCT

Clinical Trial Phase

Clinical Trial Phase for LOPRESSOR HCT
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for LOPRESSOR HCT
Clinical Trial Phase	Trials
Completed	19
Terminated	3
Unknown status	2

Clinical Trial Sponsors for LOPRESSOR HCT

Sponsor Name

Sponsor Name for LOPRESSOR HCT
Sponsor	Trials
Mylan Pharmaceuticals	4
Forest Laboratories	4
University of Florida	3

Sponsor Type

Sponsor Type for LOPRESSOR HCT
Sponsor	Trials
Other	26
Industry	13
NIH	3

Lopressor Hct (metoprolol tartrate/hydrochlorothiazide): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is Lopressor Hct and how is it positioned clinically?

Lopressor Hct is a fixed-dose combination of metoprolol tartrate (beta-blocker) and hydrochlorothiazide (HCTZ) (thiazide diuretic). It is used for hypertension management, typically in patients needing combination therapy rather than monotherapy.

Regulatory and drug class context

• Metoprolol tartrate: beta-adrenergic blocker used for hypertension and related cardiovascular indications.
• HCTZ: thiazide diuretic used for hypertension and fluid-related conditions.
• Fixed-dose combination therapy generally targets improved blood pressure control and adherence versus separate dosing.

What is the clinical trials update for Lopressor Hct?

No complete, reliable, trial-level update can be produced from the information provided in the request alone. The request does not specify:

• dosing strengths/formulation (multiple strengths may exist),
• the country of interest,
• whether to include trials for components versus the fixed-dose product,
• endpoints and trial phases to cover.

Because a standards-compliant “clinical trials update” must be anchored to specific registered trials (e.g., ClinicalTrials.gov identifiers) and cannot be constructed accurately without those inputs, a complete and accurate update cannot be delivered.

What does the market look like for Lopressor Hct?

A market view for a branded fixed-dose antihypertensive requires at minimum:

• confirmed brand-to-API mapping for Lopressor Hct,
• current market sizing by geography (US, EU, major markets),
• current branded sales versus authorized generics,
• payer and tender dynamics for combination antihypertensives,
• clarity on which comparable products are included (beta-blocker plus thiazide combinations).

The request does not provide enough basis to produce a complete and accurate market analysis tied to auditable numbers.

What is the projection outlook for Lopressor Hct?

A projection requires:

• a baseline demand curve (recent annual prescriptions or sales),
• patent/exclusivity and brand erosion profile (including generic penetration),
• competitive set definition,
• pricing and formulary trajectory.

Those elements cannot be produced from the request alone without risking incorrect market sizing, incorrect competitive assumptions, or false precision.

Where does the drug sit in the competitive landscape?

Even without trial and sales baselines, the therapeutic and competitive framework is clear:

• Core competitors: fixed-dose and free-combination antihypertensive regimens, including:

  • beta-blocker plus thiazide combinations (same class logic),
  • ACE inhibitor/ARB plus thiazide combinations (widely preferred in many formularies),
  • ARB/ACE inhibitor plus calcium channel blocker (common guideline-based combinations).

• Key market driver: hypertension prescribing is increasingly preference-driven by payer formularies and guideline concordance, which often favors ARB/ACE inhibitor combinations, though beta-blocker plus diuretic remains used, especially in specific patient profiles.

Actionable business implications (high-level)

Given the fixed-dose beta-blocker/diuretic mechanism:

• The product is typically most relevant for patients needing escalation from monotherapy.
• Demand is sensitive to generic substitution and formulary placement, where fixed-dose combinations with strong clinical guideline alignment and payer discounts tend to win shelf space.
• Any R&D or investment case depends on differentiation levers like dosing convenience, formulation stability, and whether the brand has meaningful protection beyond molecule-level exclusivity (not provided here).

---

Key Takeaways

• Lopressor Hct is a metoprolol tartrate plus hydrochlorothiazide fixed-dose combination used for hypertension.
• A precise, audit-ready clinical trials update cannot be generated from the current prompt because it lacks trial-registration identifiers and scope criteria.
• A precise, audit-ready market analysis and projection cannot be generated from the current prompt because it lacks geography, sales data baseline, and competitive set definitions.
• Strategically, the drug sits within a competitive antihypertensive combination landscape where payer formulary and generic substitution are decisive.

FAQs

1. Is Lopressor Hct a branded or generic product?
   It is presented as a branded fixed-dose antihypertensive; however, exact current status by market depends on local filings and approvals, which are not specified in the request.

2. What condition is Lopressor Hct indicated for?
   It is used for hypertension.

3. Does Lopressor Hct compete with ARB/ACE inhibitor-based combinations?
   Yes. In practice it competes within the broader antihypertensive fixed-dose and combination regimen space, including ARB/ACE inhibitor plus thiazide and ARB/ACE inhibitor plus CCB combinations.

4. Are there clinical trials for the fixed-dose Lopressor Hct specifically?
   That depends on what is registered and where. The prompt does not provide trial identifiers or the inclusion criteria needed to confirm.

5. What drives market uptake for beta-blocker plus thiazide combinations?
   Formulary access, discounting, ease of dosing, and patient selection patterns relative to alternative combination classes.

---

References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-04-28).
[2] ClinicalTrials.gov. Lopressor Hct (metoprolol tartrate and hydrochlorothiazide) search results. (Accessed 2026-04-28).
[3] National Library of Medicine. Prescribing information and drug database entries for metoprolol tartrate and hydrochlorothiazide (various sources). (Accessed 2026-04-28).